Clamping device for use with an anatomic external fixation device

ABSTRACT

A clamping device includes a clamp body and a locking assembly. The clamp body includes a first jaw defining a first opening and a second jaw defining a second opening. The locking assembly includes a first locking element, a second locking element, and a lever. The first locking element includes a first end and a shaft portion extending from the first end. The shaft portion is sized to pass through the first opening and the second opening. The locking assembly is configured to reduce a distance between the first jaw and the second jaw responsive to rotation of the second locking element. The lever is configured to attach to the second locking element and rotate about the second locking element from a first position to a second position to cause the distance between the first jaw and the second jaw to be reduced further.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/701,104, entitled “CLAMING DEVICE FOR USE WITH AN ANATOMIC EXTERNALFIXATION DEVICE,” filed Sep. 11, 2017, which is a continuation of U.S.patent application Ser. No. 15/359,479, entitled “CLAMING DEVICE FOR USEWITH AN ANATOMIC EXTERNAL FIXATION SYSTEM,” filed Nov. 22, 2016, whichis a continuation-in-part of U.S. patent application Ser. No.14/871,618, entitled “CLAMPING DEVICE FOR USE WITH AN ANATOMIC EXTERNALFIXATION SYSTEM,” filed on Sep. 30, 2015, which claims priority to U.S.Application 62/058,262, entitled “Anatomic External Fixation Device,”filed on Oct. 1, 2014, the disclosures of which are incorporated hereinby reference in their entireties for all purposes.

TECHNICAL FIELD

The present disclosure relates generally to fracture fixation systems,methods, and components. More particularly, the disclosure relates toimproved anatomic external fixation systems, methods, and components.Particular embodiments described herein can be used to set bonefragments in long or flat bone fractures (e.g., tibia fractures, femurfractures, fibula fractures, pelvis fractures, etc. . . . ).

BACKGROUND

External fixation devices have been widely used in the treatment of longbone fractures and are best suited in cases of unstable, comminutedfractures. An example of this would be a compound fracture of the tibiathat would generally be fixed with a cast. If the fracture is toocomminuted, the cast will be unable to provide enough support to thefragments, thus leading to a malunion or a nonunion. The externalfixation device helps stabilize the bone fragments and allow the patienta quicker recovery time with fewer complications.

Current external fixation devices consist of straight rods andring-frames made of carbon fiber that can be interconnected through theuse of clamps. The clamps can be two sided with one side clamping to thestraight bar and the other side clamping to a bone pin that is fixed toa bone or bone fragment. These two clamps are connected to each othervia a rotating joint joint that allows for some adjustability along oneplane, thus allowing various angles in between the rods and the pins.Once the surgeon has adjusted the rods and pins to the desiredpositions, they have to lock everything in place by tightening nuts oneach side of the clamp. The process of locking each clamp in place canbe cumbersome and may require multiple assistants to aid in theprocedure. This adds complexity and wastes valuable resources.

External fixator devices with hinges for fixing injury around jointssuch as the elbow, the knee, and the ankle are generally designed foruse only on the right side or only on the left side of the joint orlimb. These hinged systems must be mounted on the bone with themechanical pivot axis of the device aligned with the natural pivot axisof the joint. These designed limitations not only demand that hospitalsdedicate a large inventory for accommodating high volume of externalfixator devices, but also increase surgical time and complexity ininstalling the devices on patients.

Therefore, a need exists for improved external fixation systems,methods, and components for use in fracture fixation.

SUMMARY

The present disclosure provides components and systems for externallyfixing and precisely adjusting fractures in general, and moreparticularly fractures in a bone or near a joint, such as fractures nearthe elbow, knee, and ankle. The components and systems according to someexemplary embodiments wherein the same system can be used on either theright side or the left side of a bone or joint. According to some otherexemplary embodiments, a single system can be used across both sides ofthe bone or joint simultaneously. The systems and their componentsinclude unitary construction, unitary modular construction and modularconstruction.

According to an aspect of the present disclosure, a clamping device foran external fixation system includes a clamp body and a lockingassembly. The clamp body includes a first jaw and a second jaw anddefines a first channel configured to accommodate a fixation elementalong a longitudinal axis of the first channel. The first jaw defines afirst opening and the second jaw defines a second opening. The lockingassembly includes a first locking element, a second locking element, anda lever configured to couple to the second locking element. The firstlocking element includes a first end and a shaft portion extending fromthe first end. The shaft portion is sized to pass through the firstopening and the second opening. The second opening is sized to restrictthe first end from passing through the second opening. The first lockingelement defines a second channel sized to receive a bone pin. Thelocking assembly is configured to reduce a distance between the firstjaw and the second jaw responsive to rotation of the second lockingelement relative to the first locking element. The lever is configuredto attach to the second locking element and rotate about the secondlocking element from a first position to a second position to cause thedistance between the first jaw and the second jaw to be reduced furtherwhile the first end is in contact with the second opening.

According to another aspect of the present disclosure, a clamping devicefor an external fixation system includes a clamp body and a lockingassembly. The clamp body includes a first jaw and a second jaw. Thefirst jaw defines a first opening and the second jaw defines a secondopening. The locking assembly includes a first locking element, a secondlocking element, and a lever. The first locking element includes a firstend and a shaft portion extending from the first end. The shaft portionis sized to pass through the first opening and the second opening. Thelever is configured to be attached to the second locking element androtated about the second locking element to cause a distance between thefirst jaw and the second jaw to be reduced while the first lockingelement is in contact with the second opening.

Some or all of the systems, components and subcomponents of the presentinvention can be single-use or disposable. Also some or all of thesystems, components and subcomponents of the present invention can bemade of a unitary construction (formed from a single piece of metal ormaterial) or unitary modular construction (plurality of componentsand/or subcomponents permanently connected by standard means, such asinjection molding, welding, or soldering), or of modular construction(plurality of components and/or subcomponents removably connected bystandard means, such as threading or snap-fitting).

These and other features of various embodiments can be understood from areview of the following detailed description in conjunction with theaccompanying drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and arenot restrictive of the present invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a superior-lateral perspective view of an elbow with a firstembodiment of the elbow external fixator and its associated clamps.

FIG. 2 is a superior-medial perspective view of an elbow with the firstembodiment of the elbow external fixator and its associated clamps.

FIG. 3 is a superior perspective view of an elbow with the firstembodiment of the elbow external fixator and its associated clamps.

FIG. 4 is a detailed anterior-medial exploded view of the firstembodiment of the elbow external fixator.

FIG. 5 is a detailed anterior-lateral exploded view of the firstembodiment of the elbow external fixator.

FIG. 6 is a perspective view of a first embodiment of a closed clampthat can be utilized in all the embodiments of the external fixator.

FIG. 6A is a cross-sectional view taken along the line 6A-6A of FIG. 6

FIG. 7 is a perspective view of a double diameter pin that can beutilized in the first embodiment of the closed clamp.

FIG. 8 is an exploded bottom perspective view of the first embodiment ofthe closed clamp that can be utilized in all the embodiments of theexternal fixator.

FIG. 9 is an exploded side view of the first embodiment of the closedclamp that can be utilized in all the embodiments of the externalfixator.

FIG. 9A is a cross-sectional view taken along the line 9A-9A of FIG. 9

FIG. 10 is an exploded top perspective view of the first embodiment ofthe closed clamp that can be utilized in all the embodiments of theexternal fixator.

FIG. 11 is a perspective view of a first embodiment of an open clampthat can be utilized in all the embodiments of the external fixator.

FIG. 11A is a cross-sectional view taken along the line 11A-11A of FIG.11

FIG. 12 is a perspective view of a double diameter pin used in the firstembodiment of the open clamp.

FIG. 13 is an exploded top perspective view of the first embodiment ofthe open clamp that can be utilized in all the embodiments of theexternal fixator.

FIG. 14 is an exploded side view of the first embodiment of the openclamp that can be utilized in all the embodiments of the externalfixator.

FIG. 15 is an exploded bottom perspective view of the first embodimentof the open clamp that can be utilized in all the embodiments of theexternal fixator.

FIG. 15A is a cross-sectional view of a second embodiment of the openclamp system that can be utilized in all the embodiments of the externalfixator.

FIG. 15B is a cross-sectional view of the clamp body of FIG. 15A.

FIG. 15C is a side view of the shaft of FIG. 15A.

FIG. 15D is a cross-sectional view taken along the line 15D-15D of FIG.15C.

FIG. 16 is a perspective view of a third embodiment of amultiple-part/multiple-material open clamp that can be utilized in allthe embodiments of the external fixator.

FIG. 17 is an exploded perspective view of the third embodiment of themultiple-part/multiple-material open clamp that can be utilized in allthe embodiments of the external fixator.

FIG. 17A is a cross-sectional view taken along the line 17A-17A of FIG.17.

FIG. 18 is a lateral perspective view of an elbow with a secondembodiment of the elbow external fixator and its associated clamps.

FIG. 19 is a superior-lateral perspective view of an elbow with thesecond embodiment of the elbow external fixator and its associatedclamps.

FIG. 20 is a posterior-lateral perspective view of an elbow with thesecond embodiment of the elbow external fixator and its associatedclamps.

FIG. 21 is a detailed posterior-lateral exploded view of the secondembodiment of the elbow external fixator.

FIG. 21A is a cross-sectional view taken along the line 21A-21A of FIG.21.

FIG. 21B is a cross-sectional view taken along the line 21B-21B of FIG.21.

FIG. 22 is a detailed anterior-lateral exploded view of the secondembodiment of the elbow external fixator.

FIG. 22A is a cross-sectional view taken along the line 22A-22A of FIG.22.

FIG. 23 is an anterior perspective view of a leg with a first embodimentof the knee external fixator and its associated clamps.

FIG. 24 is an anterior-medial perspective view of a leg with the firstembodiment of the knee external fixator and its associated clamps.

FIG. 25 is an anterior-lateral perspective view of a leg with the firstembodiment of the knee external fixator and its associated clamps.

FIG. 26 is a detailed anterior-medial exploded view of the firstembodiment of the knee external fixator.

FIG. 27 is a detailed anterior-lateral exploded view of the firstembodiment of the knee external fixator.

FIG. 28 is an anterior perspective view of a leg with a secondembodiment of the knee external fixator and its associated clamps.

FIG. 29 is an anterior-medial perspective view of a leg with the secondembodiment of the knee external fixator and its associated clamps.

FIG. 30 is an anterior-lateral perspective view of a leg with the secondembodiment of the knee external fixator and its associated clamps.

FIG. 31 is a detailed anterior-lateral exploded view of the secondembodiment of the knee external fixator.

FIG. 32 is a detailed anterior-medial exploded view of the secondembodiment of the knee external fixator.

FIG. 33 is an anterior perspective view of a leg with a third embodimentof the knee external fixator and its associated clamps.

FIG. 34 is a superior-medial perspective view of a leg with the thirdembodiment of the knee external fixator and its associated clamps.

FIG. 35 is a superior-lateral perspective view of a leg with the thirdembodiment of the knee external fixator and its associated clamps.

FIG. 36 is a detailed superior-lateral exploded view of the thirdembodiment of the knee external fixator.

FIG. 37 is a detailed superior-medial exploded view of the thirdembodiment of the knee external fixator.

FIG. 38 is a superior-medial perspective view of a leg with a fourthembodiment of the knee external fixator and its associated clamps.

FIG. 39 is a superior-lateral perspective view of a leg with the fourthembodiment of the knee external fixator and its associated clamps.

FIG. 40 is a detailed superior-medial exploded view of the fourthembodiment of the knee external fixator.

FIG. 41 is a detailed superior-lateral exploded view of the fourthembodiment of the knee external fixator.

FIG. 42 is an anterior-medial perspective view of a leg with a firstembodiment of the ankle external fixator and its associated clamps.

FIG. 43 is an anterior-lateral perspective view of a leg with the firstembodiment of the ankle external fixator and its associated clamps.

FIG. 44 is a posterior-lateral perspective view of a leg with the firstembodiment of the ankle external fixator and its associated clamps.

FIG. 45 is an anterior-medial perspective view of a leg with a secondembodiment of the ankle external fixator and its associated clamps.

FIG. 46 is an anterior-lateral perspective view of a leg with the secondembodiment of the ankle external fixator and its associated clamps.

FIG. 47 is a posterior-medial perspective view of a leg with the secondembodiment of the ankle external fixator and its associated clamps.

FIG. 48 is an anterior-medial perspective view of a leg with a thirdembodiment of the ankle external fixator and its associated clamps.

FIG. 49 is a medial perspective view of a leg with the third embodimentof the ankle external fixator and its associated clamps.

FIG. 50 is a posterior-lateral perspective view of a leg with the thirdembodiment of the ankle external fixator and its associated clamps.

FIG. 51 is a detailed posterior-lateral exploded view of the thirdembodiment of the ankle external fixator.

FIG. 52 is a detailed posterior-medial exploded view of the thirdembodiment of the ankle external fixator.

FIG. 53 is an anterior-medial perspective view of a leg with a fourthembodiment of the ankle external fixator and its associated clamps.

FIG. 54 is a medial perspective view of a leg with the fourth embodimentof the ankle external fixator and its associated clamps.

FIG. 55 is a posterior-lateral perspective view of a leg with the fourthembodiment of the ankle external fixator and its associated clamps.

FIG. 56 is a detailed posterior-lateral view of the fourth embodiment ofthe ankle external fixator.

FIG. 57 is a detailed medial view of the fourth embodiment of the ankleexternal fixator.

FIG. 58 is a detailed posterior-lateral exploded view of the fourthembodiment of the ankle external fixator.

FIG. 59 is a detailed posterior-medial exploded view of the fourthembodiment of the ankle external fixator.

FIG. 60 is a detailed exploded view of the cartridge utilized in thefourth embodiment of the ankle external fixator.

FIG. 61 is a section view of the main body of the cartridge utilized inthe fourth embodiment of the ankle external fixator.

FIG. 62 is an anterior-medial perspective view of a leg with a fifthembodiment of the ankle external fixator and its associated clamps.

FIG. 63 is a medial perspective view of a leg with the fifth embodimentof the ankle external fixator and its associated clamps.

FIG. 64 is a posterior-inferior perspective view of a leg with the fifthembodiment of the ankle external fixator and its associated clamps.

FIG. 65 is an anterior-medial perspective view of a leg with a sixthembodiment of the ankle external fixator and its associated clamps.

FIG. 66 is a medial perspective view of a leg with the sixth embodimentof the ankle external fixator and its associated clamps.

FIG. 67 is a posterior-lateral perspective view of a leg with the sixthembodiment of the ankle external fixator and its associated clamps.

FIG. 68 is a detailed posterior-medial exploded view of the sixthembodiment of the ankle external fixator.

FIG. 69 is a detailed posterior-lateral exploded view of the sixthembodiment of the ankle external fixator.

FIG. 70 is a flow diagram of a method of fixating a bone fixator systemto a target joint of a subject.

FIG. 71 is a perspective view of an embodiment of a clamping device.

FIG. 72A is perspective view of an embodiment of a bone pin to bereceived in the clamping device of FIG. 71.

FIG. 72B is a perspective view of an embodiment of a bone pin that isreceived in the clamping device of FIG. 71.

FIG. 73A is a perspective view of an embodiment of a locking element ofa locking assembly of the clamping device of FIG. 71.

FIG. 73B is a perspective view of an embodiment of another lockingelement of the clamping device of FIG. 71.

FIG. 73C is a perspective view of an embodiment of another lockingelement of the clamping device of FIG. 71.

FIG. 73D is a perspective view of an embodiment of a lever of theclamping device of FIG. 71.

FIG. 74A is a side view of an embodiment of the clamping device of FIG.71 in which the lever is in a first position.

FIG. 74B is a side view of an embodiment of the clamping device of FIG.71 in which the lever is in a second position.

FIG. 75A is a cross section view of an embodiment of the clamping deviceof FIG. 71 in which the lever is in the first position.

FIG. 75B is a cross section view of an embodiment of the clamping deviceof FIG. 71 in which the lever is in the second position.

FIG. 76A is a side view of an embodiment of the clamping device of FIG.71 in which the bone pin is secured in a first orientation.

FIG. 76B is a side view of an embodiment of the clamping device of FIG.71 in which the bone pin is secured in a second orientation.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various exemplary external fixation systems, methods, andcomponents. The description and drawings are exemplary in nature and areprovided to enable one skilled in the art to make and use one or moreexemplary external fixation systems and/or components, and/or practiceone or more exemplary methods. They are not intended to limit the scopeof the claims in any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicates non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “optionally” andgrammatically related terms means that the subsequently describedelement, event, feature, or circumstance may or may not bepresent/occur, and that the description includes instances where saidelement, event, feature, or circumstance occurs and instances where itdoes not. The use of “exemplary” refers to “an example of” and is notintended to convey a meaning of an ideal or preferred embodiment. Theuse of “attached” and “coupled” grammatically related terms refers tothe fixed, releasable, or integrated association of two or more elementsand/or devices with or without one or more other elements in between.Thus, the term “attached” or “coupled” and grammatically related termsincludes releasably attaching or fixedly attaching two or more elementsand/or devices in the present or absence of one or more other elementsin between. As used herein, the terms “proximal” and “distal” are usedto describe opposing axial ends of the particular elements or featuresbeing described in relation to anatomical placement. As used herein, theterms “proximal,” “distal,” “inferior,” “posterior,” and any otherrelative position terms are intended to facilitate clarity regarding thedisclosed embodiments, and do not limit the disclosure to any particularframe of reference.

While the systems, methods, and components described herein areexemplified by systems and methods for external fixation of bones, thesystems, methods, and components described and illustrated herein can beused to treat any suitable ailment or joint within the body of ananimal, including, but not limited to, humans. Skilled artisans will beable to select a suitable ailment and/or joint within the body of ananimal to utilize a system and/or method described herein according to aparticular embodiment based on various considerations, including thetype of ailment and/or the structural arrangement at a treatment site.Example joints considered suitable to utilize a system, method, and/orcomponent described herein include, but are not limited to, the elbowjoint, the knee joint, and the ankle joint.

A. External Fixation Systems and Clamping Systems

In some embodiments, components disclosed herein may be disposed in asubstantially perpendicular orientation (e.g., having longitudinal axesthat are less than 20 degrees from 90 degrees apart, less than 10degrees from 90 degrees apart, less than 5 degrees from 90 degreesapart, less than 1 degree from 90 degrees apart, etc.). In someembodiments, components disclosed herein may be disposed in asubstantially coplanar (e.g., being disposed in planes that are lessthan 20 degrees from coplanar, less than 10 degrees from coplanar, lessthan 5 degrees from coplanar, less than 1 degree from coplanar, etc.).

FIGS. 1-3 illustrate an exemplary human elbow 10 comprising a humerus12, ulna 14, and radius 16 and one embodiment of an exemplaryelbow-spanning external fixation system 100.

FIGS. 1-5 illustrate a first embodiment of an exemplary elbow-spanningexternal fixation system 100 comprising a first external fixationcomponent 102, a second external fixation component 104, a fastener orlocking means 106, a closed-end clamp system 300 and an open-end clampsystem 400. The first external fixation component 102 can be adapted toattach to the humerus 12, the ulna 14 and/or the radius 16 by use of theclosed-end clamp system 300 and/or open-end clamp system 400. The secondexternal fixation component 104 can be adapted to attach to the humerus12, the ulna 14 and/or the radius 16 by use of the closed-end clampsystem 300 and/or open-end clamp system 400.

The first external fixation component 102, second external fixationcomponent 104, fastener 106, closed-end clamp system 300 and open-endclamp systems 400 and 500 (shown in FIGS. 16-17) can be formed of anysuitable material known to one skilled in the art that provides anadequate stiffness or resistance to torsion, stress, torque and/or otherforces that may be applied to the system 100, including the structuralarrangement at a fixation site and/or the material forming thecomponents of an external fixation system. Example suitable materialsinclude, but are not limited to, biocompatible materials, materials thatcan be made biocompatible, ceramics, polymers, polyethylene,ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer,carbon fiber, metal, metal alloy, shape memory metals, tantalum,titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr),cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably,but not necessarily, radiolucent. It is considered advantageous to forma first external fixation component, a second external fixationcomponent, a fastener, a closed-end clamp system and an open-end clampsystem of aluminum, stainless steel and/or carbon fiber, at leastbecause these materials have properties that are well suited to externalfixation of fractures.

In the illustrated embodiment 100 shown in FIGS. 1-5, the first externalfixation component 102 comprises a first component proximal (e.g.,first) end portion 108 and a first component distal (e.g., second) endportion 110. At least a portion of the first component proximal endportion 108 and at least a portion of the first component distal endportion 110 can be straight or curved. The first component distal endportion 110 includes a pivot structure 122 having a rough surface 124and a through-bore having a circular cross-sectional shape for receivinga fastener such as fastener 106. The second external fixation component104 comprises a second component proximal (e.g., first) end portion 112and a second component distal (e.g., second) end portion 114. At least aportion of the second component proximal end portion 112 can be straightor curved. The second component proximal end portion 112 also includes apivot structure 126 having a rough surface 128 and a threadedthrough-bore 132 having a circular cross-sectional shape for receiving afastener such as fastener 106. The first external fixation component 102and second external fixation component 104 are coupled and locked via alocking means such as a fastener 106 having a head 116 and at least aportion of its shaft threaded 120. The fastener 106 is configured toextend through the through-bore of the first pivot structure 122 and thethreaded through-bore of the second pivot structure 126 to form athreaded connection with the second pivot structure 126 to form amovable hinge, articulator or mechanical joint 130. The hinge 130 isthen locked in position by further tightening the fastener 106 whichthen interlocks the rough surface 124 of the first pivot structure 122with the rough surface 128 of the second pivot structure 126. Theinterlocking or engagement of the rough surfaces 124 and 128 preventsthe first and second external components 102 and 104 from rotatingrelatively to each other in a locking state.

Each of the first and second external fixation components 102 and 104including their respective pivot structures 122 and 126 can be formed asa unitary, prefabricated modular component (e.g. from multiple pieceswelded together), a unitary component (e.g. from a single piece ofmaterial by molding), or a modular component (e.g. multiple piecesremovably threaded together to allow surgeons to use as-is or toreconfigure to match the patient anatomy). The first and second externalfixation components 102 and 104 each can have any cross-sectional shapeincluding circular, and non-circular such as oval, square, rectangle,triangle, or any polygonal shapes, and the cross-sectional shape can bedifferent along the length of each component (e.g. semi-circle, circle).Each of the first and second external fixation components 102 and 104can have uniform or varying diameter or thickness along its length. Thefirst external fixation component 102 can be dimensioned and/or shapedto be the same or different from the second external fixation component104.

The pivot structures 122 and 126 can be integrally formed or permanentlyattached by standard means such as welding or soldering or gluing, orremovably coupled by standard means such as threading or snap-fitting,to any locations along the length of their respective first and secondexternal fixation components 102 and 104 including the portion disposedbetween the distal end portion and the proximal end portion of eachexternal fixation components 102 and 104. The pivot structures 122 and126 can have any cross-sectional shape including circular, andnon-circular such as oval, square, rectangle, triangle, or any polygonalshape. The length of each of the pivot structures 122 and 126 asmeasured along its axis of rotation or mechanical pivot axis X can bethe same or different from the diameter or thickness of their respectivefirst and second external fixation components 102 and 104. The endsurfaces 124 and 128 of pivot structures 122 and 126 comprising therough surface each lies in a plane perpendicularly intersecting themechanical pivot axis, but can also lie in a plane intersecting themechanical pivot axis at an angle other than 90 degrees. The roughsurfaces 124 and 128 can include serration or radial interdigitation orother irregularly shaped features which provide friction enhancement oranti-rotation to the fixation components in a locking state. One skilledin the art may choose to have the rough surfaces be disposed on an outersurface of one of the first and second pivot structures 122 and 126 andon an inner surface of the other of the first and second pivotstructures 122 and 126 to provide anti-rotation. The rough surfaces canalso be provided as separate inserts coupled to the pivot structures 122and 126. The pivot structures 122 and 126 can be an integral part oftheir respective external fixation components 102 or 104 or can beformed separately and assembled together later by welding, soldering orthreading, for example. The pivot structures 122 and 126 each can bemade of a unitary structure, a unitary modular or multi-componentstructure, or modular structure. An example of a modular pivot structuremay include a pivot structure 122 or 126 having a non-circularcross-sectional shaped through-bore for receiving an insert having amatching, non-circular cross-sectional shape and a circularcross-sectional shaped through-bore with or without threads.

The locking means, such as fastener 106, comprises an enlargedstructure, such as a head 116, with secure gripping surface features orgeometry 118 for ease of handling the fastener during surgery, and ashaft 120 having engagement features such as threads which establish athreaded connection with the threaded through-bore 132 of the pivotstructure 126 in the second external fixation component 104 duringcoupling and locking the external fixation components. The engagementfeatures on the shaft can also include fins, protrusions or otherfastening features known to one skilled in the art. The fastener 106 canalso be a unitary, unitary modular or modular structure. An example of amodular fastener include a fastener as described but without theengagement features on is shaft, and a sleeve having engagement featureson its outer surface adapted to cover the shaft of the fastener. Thelocking means can also include a first fastener such as fastener 106 anda second fastener such as a threaded nut. In this exemplary dualfastener system, both pivot structures 122 and 126 can havethrough-bores without threads or any engagement features, and arrangedbetween the head of the first fastener and the nut. As the firstfastener 106 or the second fastener (the threaded nut) is tighteneddown, the external fixation components 102 and 104 are coupled andlocked in position.

FIGS. 6-15 describe various embodiments of a novel bone clamp configuredto provide simple locking of various fixation elements such as wires,pins, rods and bars simultaneously. These clamping devices as describedbelow can be used with the external fixation systems of the presentinvention to couple to bones, or with any existing or commercializedexternal fixation systems.

FIGS. 6-10 show an embodiment of a closed-end clamp system 300comprising a clamp body 302, a knob 304 and a shaft 306. The clamp body302 having an open end 302 c and a close or hinged end 302 d connectingan upper jaw 302 a to a lower jaw 302 b forming a groove or aperture 308for receiving an external fixation element such as the first or secondexternal fixation components 102 and 104, and a slot or spacing 310 incommunication with the aperture 308. Each of the upper and lower jaws302 a and 302 b have a through-bore 000 formed in alignment andconfigured for receiving and operatively interacting with at least aportion of a locking element or locking assembly such as the shaft 306configured for operably interacting with the knob 304 for locking theclamp system 300.

The knob 304 comprises a knob body 304 a having a clamp body facing end304 b and an opposing end 304 c and a through-bore dimensioned forreceiving and operatively interacting with a shaft, such as shaft 306,and extending longitudinally from the clamp body facing end 304 b to theopposing end 304 c. The knob body 304 a includes a funnel-like orfrusto-conical internal surface 304 e or an internal surface having oneof more tapered facets to guide, receive and alternatively compress andrelease a slit end, or a funnel-like or tapered external surface, of ashaft such as the shaft 306 for clamping a fixation element such as bonepin 600. The funnel-like or frusto-conical internal surface 304 e, ormore generally the through-bore bound by walls extending from the clampbody facing end 304 b to the opposing end 304 c of the knob body 304 a,is designed to be larger toward the clamp body facing end 304 b thantoward the opposing end 304 c of the knob body 304 a, and includes afirst locking feature such as threads 350. The tapered internal surface304 e can also be an insert. The through-bore 002 or opening in theopposing end 304 c of the knob 304 has a diameter smaller than theuncompressed diameter of the slit end 324 of the shaft 306 to provideinterference fit among the inner surface 304 e of the knob 304, the slitend 324 and the bone pin such as bone pin 600. The opposing end 304 c ofthe knob body 304 a can include one or more slits 426 a or breakablelines as shown in FIG. 11A for accommodating a broader range ofdimensional tolerances of the bone pin 600 or 700. The knob 304 can haveirregularly shaped geometry 314 for providing a secure grip surface andoptionally a hexagonally shaped geometry 316 that interfaces with awrench.

The variable position shaft or shaft 306 includes an elongated body witha through-bore extending longitudinally along its length and dimensionedfor receiving a fixation element, such as a bone pin 600 or 700, an endportion including a stopper or an enlarged structure or structures, suchas head 318, which operatively interacts with at least a portion of aninternal surface of one of said upper and lower jaws, such as jaws 302 aand 302 b, for preventing the shaft 306 from passing completely throughthe clamp body 302 or through the jaw 302 a or 302 b, which the stopper318 first comes in contact with, and a locking or engagement featuresuch as threads 322 on the external surface of the shaft 306, and one ormore breakable lines or slits 324 on an opposing end portion of theshaft. The slits 324 can also be disposed on the stopper 318 to providesimilar compression onto the bone pin 600 or 700 during locking as shownin alternative embodiments of this invention. The tapered internalsurface 304 e of the knob body 304 a and the interaction of theengagement features such as the threads 322 and 350 guide and releasablycompress the slit end 324 of the shaft 306 to provide clamping of afixation element, such as bone pin 600. In the case where no slits areprovided to the end 324 of the shaft, or even if slits are provided, theend 324 of the shaft 306 can be tapered or have a funnel-like shape tomatch the tapered internal surface 304 e of the knob body 304 a. Aportion of the shaft 306 or the stopper 318 can include an at leastpartially spherical surface to permit the shaft 306, and thus, the bonepin 600 or 700 disposed in the through-bore of the shaft 306 to orientrelative to the clamp body 302, and can have at least one anti-rotationfeature such as protrusion 320 adapted to sit in a key way 004 in theclamp body 302. Other anti-rotation features can be pins, recesses,splines, and the like. The shaft 306 is configured to extend through theclamp body 302 via the through-bores 000 in the upper and lower jaws 302a and 302 b and into the through-bore of the knob 304 such that thestopper 318 is disposed in the clamp body 302 and at least a portion ofthe threads 322 of the shaft and the slit end 324 disposed inside theknob body 304 a. The shaft threads 322 operably engage the internalthreads 350 of the knob 304 in forming a threaded connection between theshaft 306 and the knob 304 to form a cannulation or reception forreceiving a bone pin such as bone pin 600 of uniform diameter or bonepin 700 of varying diameter.

In operation, the tightening of the knob 304 shortens the distancebetween the knob 304 and the stopper 318 and thus, flexes the upper andlower jaws 302 a and 302 b towards each other to clamp on an externalfixation element such as the first or second external fixationcomponents 102 and 104 disposed in aperture 308. Simultaneously, theslit end 324 of the shaft 306 is pushed and guided by the taperedinternal surface 304 e of the knob body 304 a toward the opposing end304 c of the knob 304 and compressed circumferentially onto the bone pin600 or 700 at the opposing end 304 c of the knob 304 as the slit end 324is pushed through the smaller opening 002 at the opposing end 304 c ofthe knob 304, and thus, clamping onto the bone pin 600 or 700 byinterference fit.

The clamp body 302 can include an annular protrusion such as a convexannular protrusion 312 disposed adjacent to the through-bore of theupper jaw 302 a for operably engaging with the clamp body facing end 304b of the knob 304 for secure engagement. The annular protrusion 312 canhave engagement features on its external convex surface to lockangularly with other engagement features on an underside of the clampbody facing end 304 b of the knob 304.

FIGS. 11-15 illustrate an alternative embodiment 400 of the closed-endclamp system 300. The open-end clamp device 400 is similar in design tothe closed-end clamp device 300 except that the groove or aperture 408is disposed adjacent to the open end 402 c of the clamp body 402. Theouter edges of the sides of the groove or aperture 408 along its lengthare chamfered to allow the clamp system 400 to easily snap onto afixation element such as fixation components 102 and 104. The knob 404has an under surface 428 having a rough surface such as a radialinterdigitation pattern operably engaging a convex protrusion 412 havinga rough surface such as circular steps disposed adjacent to thethrough-bore in the upper jaw 402 a.

FIGS. 15A-15D illustrate an alternative embodiment 2600 of the open-endclamp system 400. The open-end clamp system 2600 comprises a clamp body2602, a knob 2604 and a shaft 2606. The clamp body 2602 having an openend 2602 c and a close or hinged end 2602 d connecting an upper jaw 2602a to a lower jaw 2602 b forming a groove or aperture 2608 for receivingan external fixation element such as the first or second externalfixation components 102 and 104, and a slot or spacing 2610 incommunication with the aperture 2608. The upper and lower jaws 2602 aand 2602 b have through-bores 2000 a and 2000 b formed in at leastpartial alignment and dimensioned for receiving at least a portion of alocking element or assembly, such as the illustrated assembly comprisingthe knob 2604 and the shaft 2606. One of the through-bores 2000 a and2000 b of the upper and lower jaws 2602 a and 2602 b, such asthrough-bore 2000 b, defines a first diameter D1 and a second diameterD2, wherein D1 is smaller and located closer to the slot 2610. The innersurface 2602 e containing D1 and D2 is shown as partially spherical, butit can be conical, partially conical or frusto-conical, or faceted. Theinner surface 2602 e is configured and dimensioned to operativelyinteract with an external surface of a slit portion of the shaft 2606 toclamp onto a fixation element, such as bone pin 600 or 700, received ina through-bore formed along a length of the shaft 2606.

The knob 2604 comprises a longitudinally formed through-bore having aninternal thread and dimensioned for receiving and operativelyinteracting with the shaft 2606. Other engagement features, such as tabsand fins, can be used in place of or in addition to the thread on theinternal surface of the knob 2604. The opposing end 2604 c of the knobbody 2604 can include one or more slits, such as slits 426 a as shown inFIG. 11A for accommodating a broader range of dimensional tolerances ofthe bone pin 600 or 700. The knob 2604 can have an external surfaceand/or shape for providing a secure grip surface and optionally ahexagonally shaped geometry that interfaces with a wrench.

The variable position shaft or shaft 2606 includes an elongated bodywith a through-bore extending longitudinally along its length anddimensioned for receiving a fixation element, such as a bone pin 600 or700, a locking or engagement feature such as threads 2622 on theexternal surface of the shaft 2606, and a stopper or an enlargedstructure, such as head 2618, formed with one or more slits 2624extending longitudinally along at least a portion of the length of theshaft 2606, and operatively interacting with at least a portion of aninner surface of one of said upper and lower jaws, such as inner surface2602 e, for compressing the slit stopper 2618 to clamp onto the bone pin600 or 700. The inner surface 2602 e also, but not necessary, preventsthe shaft 2606 from passing completely through the clamp body 2602, orthrough at least one of the jaws 2602 a or 2602 b which the stopper 2618first comes in contact with, such as the jaw 2602 b. Other features anddesigns on the inner surface of the clamp body 2602, or of any of itsupper and lower jaws that operatively interact with at least a portionof the shaft 2606 to prevent the shaft 2606 from passing completelythrough are still within the spirit and scope of the present invention.The stopper 2618 has a partially spherical external shape and at leastone anti-rotation feature, such as anti-rotation pin 2620 configured tomate with a feature, such as a key way, on an inner surface of the clampbody 2602. Other anti-rotation features can be splines, recesses,protrusions or the like. Other shapes including conical and facetedexternal shapes of the stopper are considered within the spirit andscope of the present invention. The through-bore of the shaft 2606 andthe width of the slit 2624 are dimensioned to receive a fixationelement, such as bone pin 600 or 700, with very little play between theshaft 2606 and the bone pin 600 in an uncompressed state and a tight fitbetween the shaft 2606 and the bone pin 600 or 700 in a compressedstate. The shaft 2606 can comprise a tapered end. The engagement feature2622 on the external surface of the shaft 2606 can have other forms suchas fins and tabs for interacting with the corresponding engagementfeature on the inner surface of the knob 2604 to form a mechanicalconnection for clamping the fixation components and elements. The shaft2606 is configured to extend through the clamp body 2602 via thethrough-bores in the upper and lower jaws 2602 a and 2602 b and into thethrough-bore of the knob 2604 such that the stopper 2618 is disposed inthe clamp body 2602 and at least a portion of the threads 2622 of theshaft is disposed and operatively interacts with the threads on theinner surface of the knob 2604 a.

FIGS. 16-17 and 17A describe an alternate embodiment 500 of the open-endclamp system 400. The open-end clamp system 500 is of a modular type.The open-end clamp system 500 is similar to the open-end clamp system400 except that the convex annular protrusion 512 being a two-pieceinsert made of a separate upper part 504 and a separate lower part 506,and each of the parts 504 and 506 being formed with two key waysmatching the key ways on the inner surfaces of the through-bores in theupper and lower jaws 502 a and 502 b of the clamp body 502 for receivingthe anti-rotation features 320, or 420. The open-end clamp system 500further includes a separate clip or insert 508 disposed between theupper and lower jaws 502 a and 502 b of the clamp body 502 for modifyingthe space therein. The insert 508 including an upper jaw jacket 508 aconnected to a lower jaw jacket 508 b to form an insert groove 518 forlaterally receiving a fixation element such as fixation components 102or 104. A through-bore is formed in each of said upper and lower jawjackets 508 a and 508 b of the insert 508 and aligned with alignedthrough-bores formed in the upper and lower jaws 502 a and 502 b of theclamp body 502 for receiving the convex annular protrusion insert 512.The insert 508 includes a slot or spacing between said jaw jackets 508 aand 508 b and in communication with said insert groove 518 to allow theupper and lower jaws 502 a and 502 b of the clamp body 502 and the jawjackets 508 a and 508 b of the insert 508 to flex during locking andunlocking of the clamp system 500. The insert 508 is configured to havean outer cross-sectional shape (FIG. 17A) being substantially the sameas an inner cross-sectional shape of the clamp body 502 to allow theinsert 508 to easily slide into the space between the upper and lowerjaws 502 a and 502 b of the clamp body 502 and mate or attach to theinner surface of the clamp body 502. The insert groove 518 can includesplines to help secure gripping onto the fixation element.

Although the foregoing exemplary embodiments describe clamping systemshaving upper and lower jaws joined together by a hinged or closed end,the clamping systems of various embodiments of the present invention cancomprise two or pairs of two separate upper and lower jaws spaced apartvia a flexible structure, such as a spring coil surrounding a fastener,such as shaft 306, extending through the through-bores in the upper andlower jaws of the clamp to form one or more grooves for receivingexternal fixation elements such as rods, bars, pins, and a slot betweenthe upper and lower jaws to allow the jaws to flex during locking andunlocking.

FIGS. 18-20 show an exemplary embodiment of an elbow-spanning hingedexternal fixation system 200 using the external fixator system includingthe novel clamp devices of the present invention. The system 200 iscoupled to a human elbow 10 comprising a humerus 12, ulna 14, and radius16. FIGS. 21-22 show exploded views of the hinge or articulator of thesystem 200.

Now referring to FIGS. 18-22, the elbow-spanning hinged externalfixation system 200 comprising a first external fixation component 202,a second external fixation component 204, a fastener 206, a closed-endclamp system 300 and an open-end clamp system 400. The first externalfixation component 202 can be adapted to attach to the humerus 12, theulna 14 and/or the radius 16 by use of the closed-end clamp system 300and/or open-end clamp system 400 and fixation elements such as bonepins. The second external fixation component 204 can be adapted toattach to the humerus 12, the ulna 14 and/or the radius 16 by use of theclosed-end clamp system 300 and/or open-end clamp system 400.

The first external fixation component 202, second external fixationcomponent 204, fastener 206, closed-end clamp system 300 and open-endclamp system 400 can be formed of any suitable material known to oneskilled in the art that provides an adequate stiffness or resistance totorsion, stress, torque and/or other forces that may be applied to thesystem 200, including the structural arrangement at a fixation siteand/or the material forming the components of an external fixationsystem. Example suitable materials include, but are not limited to,biocompatible materials, materials that can be made biocompatible,ceramics, polymers, polyethylene, ultra-high-molecular-weightpolyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metalalloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys(e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). Thematerial is also preferably, but not necessarily, radiolucent. It isconsidered advantageous to form a first external fixation component, asecond external fixation component, a fastener, a closed-end clampsystem and an open-end clamp system of aluminum, stainless steel and/orcarbon fiber, at least because these materials have properties that arewell suited to external fixation of fractures.

In the illustrated embodiment 200 in FIGS. 18-22, the first externalfixation component 202 comprises a first component proximal (e.g.,first) end 208 having a straight portion with circular cross-sectionalshape (FIG. 21A) and a first component distal (e.g., second) end 210comprising a curved portion with a semi-circular cross-sectional shape(FIG. 21B) formed with a first pivot structure 222 having a circularcross-sectional shape (FIG. 22A), and a through-bore with an internalthread 232 and a rough end surface 224. The first component proximal end208 can be straight or curved. The second external fixation component204 comprises a straight portion of cylindrical structure and a curvedportion with semi-circular cross-sectional shape (FIG. 21B), a secondcomponent distal (e.g., first) end 214 and a second component proximal(e.g., second) end 212 comprising the curved portion formed with asecond pivot structure 226 having a circular cross-sectional shape (FIG.22A), a through-bore with no internal threads and a rough end surface228. The second component distal end 214 can be straight or curved. Eachof the first and second external fixation components 202 and 204including their respective pivot structures 222 and 226 can be formed asa unitary, prefabricated modular component (e.g. from multiple pieceswelded together), a unitary component (e.g. from a single piece ofmaterial by molding), or a modular component (e.g. multiple piecesremovably threaded together to allow surgeons to use as-is or toreconfigure to match the patient anatomy). A fastener 206 having threadson its shaft 220 is configured to extend through the through-bore in thecylindrical pivot structure 226 of the second external fixationcomponent 204 and the through-bore in the cylindrical pivot structure222 of the first external fixation component 202, and forms a threadedconnection with the cylindrical pivot structure 222. The first externalfixation component 202 and second external fixation component 204 areattached to each other via the fastener 206 to form a movable hinge orjoint 230. This movable hinge or joint 230 is then fixed in position byfurther tightening the fastener 206 which then interlocks the rough endsurface 224 of the first pivot structure 222 with the rough end surface228 of the second pivot structure 226. Thus, the first external fixationcomponent 202 and the second fixation component 204 are now locked inposition to reduce the bone fracture. The fastener 206 can have a distalend 216 with irregularly shaped external geometry 218 to provide asecure gripping surface, and a shaft 220 with engagement features thatcan interface with the engagement features such as fins or threads 232in the second external fixation component 204.

The elbow-spanning hinged external fixation system 200 uses acombination of foregoing described embodiments of novel clamp systems300, 400, and 500 for coupling the external fixation system 200 to thebone for fixing bone injury. This novel hinged system 200 significantlyreduces surgical time by providing surgeons with flexibility in usingthe system on either side of the joint/body without having to align themechanical pivot axis with the natural pivot axis of the joint, and easeof locking multiple fixation elements at once with a single tighteningof a knob.

Referring now to FIGS. 23-25, a first embodiment of an exemplaryknee-spanning external fixation system 800 is illustrated mounted on alower extremity 18 comprising a femur 20, tibia 22, fibula 24 and a foot26.

FIGS. 23-27 illustrate a first embodiment of an exemplary knee-spanningexternal fixation system 800 comprising a first external fixationcomponent 802, a second external fixation component 804, a firstfastener 806, a second fastener 808, a closed-end clamp system 300 andan open-end clamp system 400. The first external fixation component 802can be adapted to couple to the femur 20, the tibia 22, the fibula 24and/or the foot 26 by use of the closed-end clamp system 300 and/oropen-end clamp system 400. The second external fixation component 804can be adapted to attach to the femur 20, the tibia 22, the fibula 24and/or the foot 26 by use of the closed-end clamp system 300 and/oropen-end clamp system 400.

The first external fixation component 802, second external fixationcomponent 804, first fastener 806, second fastener 808, closed-end clampsystem 300 and open-end clamp system 400 can be formed of any suitablematerial known to one skilled in the art that provides an adequatestiffness or resistance to torsion, stress, torque and/or other forcesthat may be applied to the system 800, including the structuralarrangement at a fixation site and/or the material forming thecomponents of an external fixation system. Example suitable materialsinclude, but are not limited to, biocompatible materials, materials thatcan be made biocompatible, ceramics, polymers, polyethylene,ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer,carbon fiber, metal, metal alloy, shape memory metals, tantalum,titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr),cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably,but not necessarily, radiolucent. It is considered advantageous to forma first external fixation component, a second external fixationcomponent, a fastener, a closed-end clamp system and an open-end clampsystem of aluminum, stainless steel and/or carbon fiber, at leastbecause these materials have properties that are well suited to externalfixation of fractures.

In the illustrated embodiment 800 in FIGS. 23-27, the first externalfixation component 802 comprises a straight portion of cylindricalstructure and a curved portion also of cylindrical structure, a firstcomponent proximal (e.g., first) end 810 and a first component distal(e.g., second) end 812 comprising the curved portion formed with a pivotstructure of cylindrical body 814 having a through-bore bound by smoothwalls extending along its pivot axis and further having a rough endsurface 834. The first component proximal end 810 can be straight orcurved. The second external fixation component 804 comprises a straightportion of cylindrical structure and a curved portion also ofcylindrical structure, a second component distal (e.g., first) end 818and a second component proximal (e.g., second) end 816 comprising thecurved portion formed with a pivot structure of cylindrical body 820having a through-bore bound by smooth walls extending along its pivotaxis and a rough end surface 836. The second component distal end 818can be straight or curved. The pivot structures 814 and 820 each has alength along the pivot axis such that when the two pivot structures 814and 820 are joined end to end at their rough surfaces by a fastener,such as 806 or 808, the first external fixation component 802 and thesecond external fixation component 804 are disposed on different sidesof the bone or knee (e.g., right side, left side, anterior, posterior).Each of the first and second external fixation components 802 and 804including their respective pivot structures 814 and 820 can be formed asa unitary, prefabricated modular component (e.g. from multiple pieceswelded together), a unitary component (e.g. from a single piece ofmaterial by molding), or a modular component (e.g. multiple piecesremovably threaded together to allow surgeons to use as-is or toreconfigure to match the patient anatomy). A fastener 806 having threads826 on its shaft is configured to extend through the through-bore in thecylindrical pivot structure 814 of the first external fixation component802 and the through-bore in the cylindrical pivot structure 820 of thesecond external fixation component 804 and into a second fastener suchas a threaded nut 808, and forms a threaded connection with the nut 808.The first external fixation component 802 and second external fixationcomponent 804 are thus attached to each other via the coupling andinteractions of the pivot structures 814 and 820 and the fasteners 806and 808 to form a movable hinge or joint 838. This movable hinge orjoint 838 is then locked in position by further tightening the fasteners806 and 808 which interlocks the rough end surface 834 of the firstexternal fixation component 802 with the rough end surface 836 of thesecond external fixation component 804. The fastener 806 can have adistal end or head 822 with irregularly shaped external geometry 824 toprovide a secure gripping surface, and a shaft with engagement featuressuch as threads 826 that can interface with the engagement features suchas fins or threads inside the second fastener 808. Similarly, the secondfastener 808 can also have an outer surface geometry for secure grippingsurface.

FIGS. 28-32 illustrate an alternative embodiment 900 of the exemplaryknee-spanning external fixation system 800 comprising a first externalfixation component 902, a second external fixation component 904, afirst fastener 906, a second fastener 908 and an open-end clamp system400. The first external fixation component 902 can be adapted to attachto the femur 20, the tibia 22, the fibula 24 and/or the foot 26 by useof the closed-end clamp system 300 and/or open-end clamp system 400. Thesecond external fixation component 904 can be adapted to attach to thefemur 20, the tibia 22, the fibula 24 and/or the foot 26 by use of aclosed-end clamp system 300 and/or open-end clamp system 400.

The exemplary knee-spanning external fixation system 900 is similar tothe foregoing described system 800 except that the lockable and movablehinge of the knee-spanning external fixation system 900 is dimensionedto accommodate a wider joint or bone size. This is made possible bydesigning the pivot structures 914 and 920 to have a longer length alongtheir mechanical pivot axis for accommodating a broader range of pinsites and/or body or joint sizes.

FIGS. 33-37 show a third embodiment of an exemplary knee-spanningexternal fixation system 1000 for mounting on a lower extremity 18comprising a femur 20, tibia 22, fibula 24 and a foot 26.

The third embodiment of an exemplary knee-spanning external fixationsystem 1000 comprises a first external fixation component 1002, a secondexternal fixation component 1004, a first fastener 1006, a secondfastener 1008 and an open-end clamp system 400 or a close-end clampsystem 300. The first external fixation component 1002 can be adapted tocouple to the femur 20, the tibia 22, the fibula 24 and/or the foot 26by use of the closed-end clamp system 300 and/or open-end clamp system400. The second external fixation component 1004 can be adapted tocouple to the femur 20, the tibia 22, the fibula 24 and/or the foot 26by use of a closed-end clamp system 300 and/or open-end clamp system400.

The first external fixation component 1002, second external fixationcomponent 1004, first fastener 1006, second fastener 1008 and open-endclamp system 400 and optionally close-end clamp system 300 can be formedof any suitable material known to one skilled in the art that providesan adequate stiffness or resistance to torsion, stress, torque and/orother forces that may be applied to the system 1000, including thestructural arrangement at a fixation site and/or the material formingthe components of an external fixation system. Example suitablematerials include, but are not limited to, biocompatible materials,materials that can be made biocompatible, ceramics, polymers,polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shapememory polymer, carbon fiber, metal, metal alloy, shape memory metals,tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium(CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is alsopreferably, but not necessarily, radiolucent. It is consideredadvantageous to form a first external fixation component, a secondexternal fixation component, a fastener, a closed-end clamp system andan open-end clamp system of aluminum, stainless steel and/or carbonfiber, at least because these materials have properties that are wellsuited to external fixation of fractures.

In the illustrated embodiment 1000 in FIGS. 33-37, the first externalfixation component 1002 having an “L” shape and a circularcross-sectional shape, comprises a first component proximal (e.g.,first) end portion 1010 and a first component distal (e.g., second) endportion 1012. The first component distal end portion 1012 comprises theshorter leg of the “L” shape and is coupled to or formed at its open enda pivot structure of cylindrical body 1014 having a through-bore boundby smooth walls extending along its pivot axis and a rough end surface1034. The first component distal end portion 1012 comprises a straightmiddle segment connecting two curved end segments. However, thesesegments can all be straight or curved. The first component proximal end1010 can be straight or curved. The second external fixation component1004 having an inverted “L” shape, comprises a second component proximal(e.g., second) end portion 1016 and a second component distal (e.g.,second) end portion 1018. The second component proximal end portion 1016comprises the shorter leg of the inverted “L” shape and is coupled to,or formed at, its open end a pivot structure of cylindrical body 1020having a through-bore bound by smooth walls extending along its pivotaxis and a rough end surface 1036. The second component proximal endportion 1016 comprises a straight middle segment connecting two curvedend segments. However, these segments can all be straight or curved. Thesecond component distal end portion 1018 can be straight or curved. Thepivot structures 1014 and 1020 each has a length along the pivot axissuch that when the two pivot structures 1014 and 1020 are joined end toend at their rough surfaces 1034 and 1036 by a fastener, the firstexternal fixation component 1002 and the second external fixationcomponent 1004 are disposed on different sides of the bone or knee(e.g., right side, left side, anterior, posterior). Each of the firstand second external fixation components 1002 and 1004 including theirrespective pivot structures 1014 and 1020 can be formed as a unitary,prefabricated modular component (e.g. from multiple pieces weldedtogether), a unitary component (e.g. from a single piece of material bymolding), or a modular component (e.g. multiple pieces removablythreaded together to allow surgeons to use as-is or to reconfigure tomatch the patient anatomy).

A fastener 1006 having threads 1026 on its shaft is configured to extendthrough the through-bore in the cylindrical pivot structure 1014 of thefirst external fixation component 1002 and the through-bore in thecylindrical pivot structure 1020 of the second external fixationcomponent 1004 and into a second fastener such as a threaded nut 1008,and forms a threaded connection with the nut 1008. The first externalfixation component 1002 and second external fixation component 1004 arethus attached to each other via fasteners 1006 and 1008 to form amovable hinge or joint 1038. This movable hinge or joint 1038 is thenlocked in position by further tightening the fasteners 1006 and 1008which interlocks the rough end surface 1034 of the pivot structure 1014with the rough end surface 1036 of the pivot structure 1020. Thefastener 1006 can have a distal end or head 1022 with irregularly shapedexternal geometry 1024 to provide a secure gripping surface, and a shaftwith engagement features such as threads 1026 that can interface withthe engagement features such as fins or threads inside the secondfastener 1008. Similarly, the second fastener 1008 can also have anouter surface geometry for secure gripping surface.

In this exemplary embodiment, the first component distal end portion1012 and the second component proximal end portion 1016 form a rightangle with their respective first component proximal end portion 1010and second component distal end portion 1018. One skilled in the art canselect other angles such as 60 or 120 degrees to accommodate the type offracture or body shape, for example. Other shapes and dimensions of thefirst and second external fixation components 1002 and 1004 also arewithin the spirit and scope of various embodiments of the presentinvention. Similarly, the angles (e1, e2) between the pivot structures1014 and 1020 and their respective first component distal end portion1012 and second component proximal end portion 1016 are 90 degrees asschematically illustrated in FIGS. 33-37, but angles other than 90degrees are contemplated and within the spirit and scope of variousembodiments of the present invention.

The first external fixation component 1002 and the second externalfixation component 1004 including their respective pivot structures 1014and 1020 can each be formed as a unitary modular structure or a modularstructure. In the case of a unitary modular structure, for example, thefirst external fixation component 1002 can be formed from a single rodor bar and bent into the “L” shape, and welded to the pivot structure1014. In the case of a modular structure, the first external fixationcomponent 1002 and the pivot structure 1014 can be formed by removablyconnecting plurality of straight and/or curved rod segments and thepivot structure 1014 by snap-fitting, or threading, for example. Thefirst and second external fixation components 1002 and 1004 and thepivot structures 1014 and 1020 can have any cross-sectional shapes (e.g.hexagonal, oval, square) and dimensions other than the circularcross-sectional shape as schematically illustrated in FIGS. 33-37.

Referring now to FIGS. 38-39, an alternative embodiment 1100 of theexemplary knee-spanning external fixation system 1000 is shown mountedby pins on the lower extremity 18 comprising a femur 20, tibia 22,fibula 24 and a foot 26.

The knee-spanning external fixation system 1100 illustrated in FIGS.38-41 is similar to exemplary knee-spanning external fixation system1000 in FIGS. 33-37 except that the first component distal (e.g., first)end 1112 and the second component proximal (e.g., second) end 1116 areeach connected to their respective pivot structures 1114 and 1120 at anangle greater than 90 degrees (e3, e4).

FIGS. 42-69 show various exemplary ankle-spanning external fixationsystems, some are of unitary, prefabricated modular construction (e.g.from multiple pieces welded together), or unitary construction (e.g.from a single piece of material by molding), while others are of modularconstruction (e.g. multiple pieces removably threaded together to allowsurgeons to use the assembled system as is or to reconfigure theassembled system to match the patient anatomy). The illustratedankle-spanning external fixation systems comprise a proximal or upperframe coupled to a distal or lower frame such as the curved foot frameincluding a posterior frame segment extending angularly from and abovean inferior frame segment designed for placement and use substantiallyadjacent to the ankle area of the body to protect both the posterior andthe inferior of a foot or ankle while healing is taken place. The systemcan be used adjacent to other joints such as the elbow or the knee, andis capable of being any shape and size that allows for support of thejoint and area round the joint such as the foot, ankle, and/or lowerextremity.

Referring now to FIGS. 42-44, a first embodiment of an exemplaryankle-spanning external fixation system 1200 is shown mounted via pinson an exemplary lower extremity 28 comprising a tibia 32, fibula 34 anda foot 36. The fixation system 1200 includes one or more open-end clamps400 and 1300 and optionally closed-end clamps for clamping fixationelements such as bars, rods, pins, or wires of various diameters.

The external fixation system 1200 and open-end clamp systems 400 and1300 can be formed of any suitable material known to one skilled in theart that provides an adequate stiffness or resistance to torsion,stress, torque and/or other forces that may be applied to the system1200, including the structural arrangement at a fixation site and/or thematerial forming the components of an external fixation system. Examplesuitable materials include, but are not limited to, biocompatiblematerials, materials that can be made biocompatible, ceramics, polymers,polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shapememory polymer, carbon fiber, metal, metal alloy, shape memory metals,tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium(CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is alsopreferably, but not necessarily, radiolucent. It is consideredadvantageous to form the system 1200 of aluminum, stainless steel and/orcarbon fiber, at least because these materials have properties that arewell suited to external fixation of fractures.

The illustrated embodiment 1200 in FIGS. 42-44 comprises twoankle-spanning external fixation systems 1200 which are substantiallythe same and mounted on each side of the foot to protect the ankle andarea around the ankle. Each external fixation system 1200 comprises asingle piece, unitary prefabricated modular frame comprising a proximal(e.g., first) frame 1200 a, a connector 1214 and 1216 and a distal(e.g., second) frame 1212 attached together by standard means, such aswelding, soldering, brazing, crimping, or adhesives. The proximal framedefines a single bar or rod such as bar 1200 a including a proximal(e.g., first) end portion 1202 and a distal (e.g., second) end portion1204 and a curved portion 1206 connecting the proximal and distal endportions 1202 and 1204. The distal end 1204 can be of a reduced diameter1208 and comprises an extension or outrigger 1210 which can be dividedinto two or more branches, such as bifurcation 1220, for attaching aclamp such as the open-end clamp system 300 or closed-end clamp system400. A distal frame, such as the foot frame 1212, configured to capturethe posterior and the inferior aspects of a joint, such as the ankle,comprising two parallel curved rods 1218, is coupled to the proximalframe, such as the bar 1200 a, via a Y-shaped connector having two arms1216 and a trunk 1214. Other shapes of the connector also are within thespirit and scope of various embodiments of the present invention. Eachcurved rod 1218 comprises a straight inferior (e.g., first) framesection or portion 1218 a and a straight posterior (e.g., second) framesection or portion 1218 b and a curved frame section or portion 1218 cconnecting the straight inferior frame section 1218 a to the straightposterior frame section 1218 b, wherein said inferior frame portion 1218a and said posterior frame portion 1218 b are operatively disposed in atleast partially surrounding and spatial relation to the ankle or theheel of the foot 36, wherein said posterior frame portion 1218 b extendsangularly from and above said inferior frame portion 1218 a. Each arm1216 of the Y-shaped connector connects to one of the rods 1218 of thefoot frame 1212 at the concave surface side of the curved frame section,and the trunk 1214 of the Y-shaped connector connects to the curvedportion 1206 of the proximal frame such as the bar frame 1200 a at theconvex surface side of the curved portion 1206.

The foot frame 1212 is generally configured to capture the posterior andthe inferior aspects of a foot or ankle and thus may take various shapesas illustrated in other exemplary embodiments. In the single piece,unitary modular construction, the proximal and distal frames 1200 a and1212 and connector(s) 1214 and 1216 and their subcomponents such asoutrigger 1220 can be welded, soldered, crimped, brazed or glued/epoxiedtogether during manufacturing. Alternatively, in a unitary construction,the proximal frame 1200 a, the connector 1214 and 1216 and the distalframe 1212 and optionally any subcomponents such as an outrigger 1220may be integral-machined or formed from a single piece of metal or othermaterial by standard means such as molding or machining. In amulti-piece, or modular construction, the proximal and distal frames1200 a and 1212 and connector 1214 and 1216 and their subcomponents 1220can be removably connected by standard means such as threads,plug-socket joint, snap-fit, interference fit or a combination thereofduring manufacturing or immediately prior to use to provide surgeons theflexibility of design choices to fit the patient anatomy. The proximaland distal end portions 1202 and 1204 of the bar frame 1200 a and theY-shaped connector may be formed of various curved and/or straightpieces or subcomponents connected together and may have any profiles.The components of the system 1200 are shown as having circularcross-sectional shape. Other cross-sectional shapes such as hexagonalshape, square, rectangle, for example, are within the spirit and scopeof the various embodiments of the present invention.

Referring now to FIGS. 45-47, an alternative embodiment 1400 of theexemplary ankle-spanning external fixation system 1200 is shown mountedby pins on the lower extremity 28 comprising a femur 30, tibia 32,fibula 34 and a foot 36, wherein the foot frame is of a differentdesign.

The exemplary ankle-spanning external fixation system 1400 comprises asingle piece, unitary prefabricated modular frame comprising a proximal(e.g., first) frame 1400 a, a connector 1414 and a distal (e.g., second)frame 1412 attached together by standard means such as welding,soldering, brazing, crimping, or adhesives. Alternatively, the proximalframe, the connector and the distal frame may be integral-machined orformed from a single piece of metal or other material by standard meanssuch as molding or machining. The exemplary ankle-spanning externalfixation system 1400 comprises a proximal frame such as bar frame 1400 acoupled to a distal frame such as a foot frame 1412 via a frameconnector 1414 wherein the foot frame comprises a continuous elongatedring frame having a U-shaped inferior (e.g., first) frame section 1418lying in a first plane and a U-shaped posterior (e.g., second) framesection 1416 lying in a second plane and a curved section 1420connecting each of the legs of the U-shape inferior frame section 1418to each of those of the U-shaped posterior frame section 1416 to form aclosed loop. Other shapes of the inferior and posterior frame portionsare also within the spirit and scope of various embodiments of thepresent invention. The first and second planes containing the inferiorframe section 1418 and the posterior frame section 1416 areperpendicular to each other as schematically illustrated. However, theangle between the first and second planes can be other than 90 degrees,such as 60 degrees or 120 degrees. Said inferior frame portion 1418 andsaid posterior frame portion 1416 are operatively disposed in at leastpartially surrounding and spatial relation to the ankle or the heel ofthe foot 36, wherein said posterior frame portion 1416 extends angularlyfrom and above said inferior frame portion 1418. In the single piece,unitary modular construction, the proximal and distal frames 1400 a and1412 and connector(s) 1414 and their subcomponents such as outrigger1410 can be welded, soldered, crimped, brazed or glued/epoxied togetherduring manufacturing. Alternatively, in a unitary construction, theproximal frame 1400 a, the connector 1414 and the distal frame 1412 andoptionally any subcomponents such as an outrigger 1410 may beintegral-machined or formed from a single piece of metal or othermaterial by standard means such as molding or machining. In amulti-piece, or modular construction, the proximal and distal frames1400 a and 1412 and connector 1414 and their subcomponents 1410 can beremovably connected by standard means, such as threads, plug-socketjoint, snap-fit, interference fit or a combination thereof duringmanufacturing or immediately prior to use to provide surgeons theflexibility of design choices to fit the patient anatomy. All thecomponents of the frames and the frame connector can have circularcross-sectional shape as shown or can have other cross-sectional shapeincluding square, oval, hexagon, or others. Each of the proximal anddistal frames can be made from a single rod/bar or a plurality ofstraight and/or curved bar/rod segments or subcomponents connectedtogether end-to-end using welding, soldering, gluing, brazing, crimping,threading, snap-fitting or the like.

Referring now to FIGS. 48-50, a third embodiment of an exemplaryankle-spanning external fixation system 1500 is illustrated mounted on alower extremity 28 comprising a tibia 32, fibula 34 and a foot 36.

FIGS. 48-52 illustrate a third embodiment of an exemplary ankle-spanningexternal fixation system 1500 comprises a proximal frame including afirst external fixation component 1502 a, a second external fixationcomponent 1502 b, and a fastener 1506, and connecting to a distal (e.g.,first) frame such as foot frame 1504, and open-end clamp systems 400 and1300. The ankle-spanning external fixation system 1500 can be adapted tocouple to the tibia 32, the fibula 34 and/or the foot 36 by use of aclosed-end clamp system 300 and/or the open-end clamp systems 400 and1300.

The first and second external fixation components 1502 a and 1502 b, andthe foot frame 1504, fastener 1506 and open-end clamp systems 400 and1300 can be formed of any suitable material known to one skilled in theart that provides an adequate stiffness or resistance to torsion,stress, torque and/or other forces that may be applied to the system1500, including the structural arrangement at a fixation site and/or thematerial forming the components of an external fixation system. Examplesuitable materials include, but are not limited to, biocompatiblematerials, materials that can be made biocompatible, ceramics, polymers,polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shapememory polymer, carbon fiber, metal, metal alloy, shape memory metals,tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium(CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is alsopreferably, but not necessarily, radiolucent. It is consideredadvantageous to form the first external fixation component, the secondexternal fixation component, the foot frame, the fastener, and theopen-end clamp systems of aluminum, stainless steel and/or carbon fiber,at least because these materials have properties that are well suited toexternal fixation of fractures.

In the illustrated embodiment 1500 in FIGS. 48-52, a proximal (e.g.,second) bar frame comprises a first external fixation component 1502 acomprising a straight first component proximal (e.g., first) end portion1508 and a curved first component distal (e.g., second) end portion 1510including a first pivot structure 1512 a comprising a rough surface 1514a and a threaded shaft centered and formed perpendicularly on the roughsurface 1514 a, and said first external fixation component 1502 apivotedly coupled and locked to a second external fixation component1502 b comprising a straight second component proximal (e.g., first) endportion 1534, a straight second component distal (e.g., second) endportion 1518 of a reduced diameter, and a curved or arc portion 1532connecting the second component proximal end portion 1534 and a secondcomponent distal end portion 1518, said arc portion 1532 having a pivotstructure 1512 b with a rough surface 1514 b and a centered through-borefor receiving the threaded shaft of the pivot structure 1512 a to form amovable joint or hinge. A fastener, such as threaded nut 1506, iscoupled to the threaded shaft of the first pivot structure 1512 a toform a threaded connection to lock the movable joint, thus, also lockingthe first and second external fixation component 1502 a and 1502 b inplace. The interaction between the rough surfaces 1514 a and 1514 b in alocking state provides anti-rotation to the first and second fixationcomponents 1502 a and 1502 b. The second component proximal end portion1534 is attached by, for example, welding, soldering or gluing to adistal frame, such as the foot frame 1504, to form a unitary,prefabricated modular structure. Alternatively, the foot frame 1504 canbe integrally machined or formed with the second external fixationcomponent 1502 b from a single piece of metal or other material to forma unitary structure. The foot frame 1504 comprises a straight posteriorsegment 1516 a, a straight inferior segment 1516 b, and a curved or arcsegment 1516 c connecting the straight posterior segment 1516 a and thestraight inferior segment 1516 b to form a curved frame or rod or barfor protecting and supporting both the posterior and the inferioraspects of a foot or joint such as the ankle while healing is takenplace. Said inferior frame portion 1516 b and said posterior frameportion 1516 a are operatively disposed in at least partiallysurrounding and spatial relation to the ankle or the heel of the foot36, wherein said posterior frame portion 1516 a extends angularly fromand above said inferior frame portion 1516 b. The second componentdistal end portion 1518 has a smaller diameter and is attached (e.g.welded, soldered or glued) to an outrigger 1522 used as a clampattachment, for example. The outrigger 1522 can also be integrallymachined or formed with the second external fixation component 1502 b.

The first and second component proximal end portions 1508 and 1534, thefirst and second component distal end portions 1510 and 1518, and moregenerally the first and second external fixation components 1502 a and1502 b and the posterior and inferior segments 1516 a and 1516 b can bestraight or curved. The first and second external fixation components1502 a and 1502 b and the foot frame 1504 of the system 1500 can haveany cross-sectional shapes such as circle, square, rectangle, hexagon,etc., and can have uniform diameter or varied diameter along theirlengths. The first and second external fixation components 1502 a and1502 b including the foot frame 1504 of the system 1500 can each beformed as a unitary, prefabricated modular component (e.g. from multiplepieces welded together), a unitary component (e.g. from a single pieceof material by molding), or a modular component (e.g. multiple piecesremovably threaded together to allow surgeons to use as-is or toreconfigure to match the patient anatomy).

The pivot structures 1512 a and 1512 b can have any cross-sectionalshapes, not just limited to a circular shape as illustrated in thisexample. The pivot structures 1512 a and 1512 b can also have anylengths or thickness as measured along its pivot axis. The pivotstructures 1512 a and 1512 b of the movable hinge or joint can each alsobe an integral part of (e.g. integrally formed with) or a separate partto (e.g. removably coupled to) their respective first external fixationcomponent 1502 a and second external fixation component 1502 b. Therough surfaces 1514 a and 1514 b can include serration or radialinterdigitation or combinations thereof. In a system where both pivotstructures 1512 a and 1512 b each comprises a through-bore, a secondfastener having a head and a threaded shaft can be used to couple thepivot structures 1512 a and 1512 b and operably interacts with thethreaded nut 1506 to lock the pivot structures 1512 a and 1512 b. Thefastener(s) can have a secure gripping surface for ease of handlingduring surgery. As illustrated, the first external fixation component1502 a and the second external fixation component 1502 b including thefoot frame 1504 each is made as a unitary modular structure. In themodular structure, the first external fixation component 1502 a and thesecond external fixation component 1502 b and the foot frame 1504 caneach be made from a plurality of straight and/or curved segmentsconnected via threads, snap-fit or interference fit.

Referring now to FIGS. 53-57, a fourth embodiment of an exemplaryankle-spanning external fixation system 1600 is shown mounted on anexemplary lower leg 28 comprising a tibia 32, fibula 34 and a foot 36.

FIGS. 53-61 illustrate a fourth embodiment of an exemplaryankle-spanning external fixation system 1600 comprising a proximal(e.g., first) frame having a first external fixation component 1602 anda second external fixation component 1604, a proximal frame connector1606, and a distal (e.g., second) frame or a foot frame 1608, a distalframe connector 1650, a cartridge system 1610 and an open-end clampsystem 400. The ankle-spanning external fixation system 1600 can beadapted to attach to the tibia 32, the fibula 34 and/or the foot 36 byuse of a closed-end clamp system 300 and/or the open-end clamp systems400 and 1300 and other fixation elements such as bone pins 600 or 700.

The first external fixation component 1602, the second external fixationcomponent 1604, the proximal (e.g., first) frame connector 1606, thefoot frame 1608, the distal (e.g., second) frame connector 1650, thecartridge system 1610 and the open-end clamp system 400 can be formed ofany suitable material known to one skilled in the art that provides anadequate stiffness or resistance to torsion, stress, torque and/or otherforces that may be applied to the system 1600, including the structuralarrangement at a fixation site and/or the material forming thecomponents of an external fixation system. Example suitable materialsinclude, but are not limited to, biocompatible materials, materials thatcan be made biocompatible, ceramics, polymers, polyethylene,ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer,carbon fiber, metal, metal alloy, shape memory metals, tantalum,titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr),cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably,but not necessarily, radiolucent. It is considered advantageous to formthe first external fixation component, the second external fixationcomponent, the third external fixation component, the fourth externalfixation component, the cartridge system and the open-end clamp systemof aluminum, stainless steel and/or carbon fiber, at least because thesematerials have properties that are well suited to external fixation offractures.

In the illustrated embodiment 1600 in FIGS. 53-61, the proximal framecomprises the first external fixation component 1602 and the secondexternal fixation component 1604. The external fixation component 1602comprises a first component proximal (e.g., first) end portion 1612 anda first component distal (e.g., second) end portion 1614 integrallyformed with or coupled to a pivot structure 1616 having a rough surface1618 and a through-bore bound by an inner surface having engagementfeatures such as threads and key ways 1620 configured for receiving andconnecting to at least a portion of the cartridge system 1610 forcoupling to a bone and locking the system 1600. The second externalfixation component 1604 comprises a second component distal (e.g.,first) end portion 1624 and a second component proximal (e.g., second)end portion 1622 integrally formed with or coupled to a pivot structure1626 having a rough surface 1628 and a through-bore bound by an innersurface having engagement features such as threads and key ways 1630configured for receiving and connecting to at least a portion of thecartridge system 1610 for coupling to a bone and locking the externalfixation components 1602 and 1604 in position.

The first and second external fixation components 1602 and 1604 can beformed as a unitary, prefabricated modular component (e.g. from multiplepieces welded together), a unitary component (e.g. from a single pieceof material by molding), or a modular component (e.g. multiple piecesremovably threaded together to allow surgeons to use as-is or toreconfigure to match the patient anatomy). The first and secondcomponent proximal end portions 1612 and 1622 and the first and secondcomponent distal end portions 1614 and 1624 can be straight or curved.The first and second external fixation components 1602 and 1604 can haveany cross-sectional shapes such as circle, oval, triangle, rectangle,square, polygonal shape. The first and second external fixationcomponents 1602 and 1604 can have any uniform or varied diameter orthickness along their lengths. The pivot structures 1616 and 1626 canhave any external cross-sectional shapes, not limited to just circularshape as illustrated in this example. The pivot structures 1616 and 1626can also have any lengths or thickness as measured along its pivot axis.The pivot structures 1616 and 1626 can also be integrally formed with orremovably coupled to their respective first external fixation component1602 and second external fixation component 1604. The rough surfaces1618 and 1628 can include serration or radial interdigitation orcombinations thereof.

The proximal frame connector 1606 comprises an elongated body comprisinga connector proximal end portion 1634 integrally formed with or coupledto a pivot structure 1636 having a rough surface 1638 and an opposingrough surface 1640 and a through-bore connecting the two opposingsurfaces 1638 and 1640 bound by an inner surface configured (e.g. keyways 1642) for receiving and locking onto at least a portion of thecartridge system 1610, and a bifurcated connector distal end portionincluding a pair of movable portions 1644 that are movable to flextoward and away from each other and arranged with one or moreprotrusions 1648 to engage with a hole 1654 in a distal frame connector1650 of the lower frame such as the foot frame 1608.

The distal frame such as the foot frame 1608 comprises a ring frameconfigured to protect both the posterior and inferior aspects of a footor the ankle. The ring frame comprises a multiple curved elongated bodystructure defining a first curved side rod spaced apart and parallel toa second curved side rod wherein a first end connector extending fromsaid first curved side rod to said second curved side rod in saidinferior portion and a second end connector extending from said firstcurved side rod to said second curved side rod in said posteriorportion. Said inferior frame portion and said posterior frame portionare operatively disposed in at least partially surrounding and spatialrelation to the ankle or the heel of the foot 36, wherein said posteriorframe portion extends angularly from and above said inferior frameportion. The foot frame 1608 has a curvature from inferior to posteriorwith its concave surface orienting toward the heel of the foot. The footframe 1608 further comprises a distal frame connector 1650 with athrough-bore extending longitudinally through at least a portion of theelongated body 1650 for receiving the bifurcated connector distal endportion 1644, and one or more holes 1654 for engaging with the one ormore protrusions 1648 on the bifurcated connector distal end portion1644. The elongated body 1650 is attached to a portion of one of thefirst and second curve side rods. The arrangement of the multiple holes1654 along the distal frame connector 1650 provides adjustability to thespatial relation between the foot frame 1608 and the heel or the ankle.The foot frame including the distal frame connector and the proximalframe connector can be formed as a unitary, prefabricated modularcomponent (e.g. from multiple pieces welded together), a unitarycomponent (e.g. from a single piece of material by molding), or amodular component (e.g. multiple pieces removably threaded together toallow surgeons to use as-is or to reconfigure to match the patientanatomy).

The cartridge system 1610 for coupling the system to a bone portion viaa bone pin 600 or 700 and locking the pivot structures 1616, 1626, and1636, and thus, also locking the ankle-spanning external fixation system1600 comprises a knob 1658, a main body 1660, a variable position shaft1662 and a retaining clip 1664.

The knob 1658 comprises a knob body 1658 a having a main body facing end1658 b and an opposing end 1658 c. The knob body 1658 a includes afunnel-like or frusto-conical internal surface or an internal surfacehaving one or more tapered facets to receive and alternativelycircumferentially compress and release a slit end or a funnel-like ortapered external surface of the shaft 1662 for clamping a fixationelement such as bone pin 600. The funnel-like or frusto-conical internalsurface or more generally the through-bore bound by walls extending fromthe main body facing end 1658 b to the opposing end 1658 c of the knobbody 1658 a is designed to be larger toward the main body facing end1658 b than toward the opposing end 1658 c of the knob body 1658 a, andincludes a first locking feature such as threads 1658 d. The tapered orconical internal surface inside the knob body 1658 a can be replacedwith a taper insert. The opposing end 1658 c of the knob body 1658 a caninclude one or more slits or breakable lines for accommodating a broaderrange of dimensional tolerances of the bone pin 600 or 700. The knob1658 can have irregularly shaped geometry 1666 for providing a securegrip surface and optionally a hexagonally shaped geometry 1668 thatinterfaces with a wrench.

The variable position shaft or shaft 1662 includes an end portionincluding a stopper or an enlarged structure or structures such as ahead 0016 for preventing the shaft 1662 from passing completely throughthe main body 1660, and a locking or engagement feature such as threads1678 on the external surface of the shaft 1662, and one or morebreakable lines or slits 1672 on an opposing end portion of the shaft.The slit end 1672 of the shaft 1662 can be tapered to match the taperedinternal surface of the knob body 1658 a. The funnel like or taperedinternal surface of the knob body 1658 a preferably interacts via theengagement features, such as the threads 1658 d and 1678, with theexternally tapered or funnel-like surface or the slit end 1672 of theshaft 1662 to provide clamping. The through-bore or opening in theopposing end 1658 c of the knob 1658 has a diameter smaller than theuncompressed diameter of the slit end 1672 of the shaft 1662 to provideinterference fit among the inner surface of the knob 1658, the slit end1672 and the bone pin such as bone pin 600 or 700. The shaft 1662 isconfigured to extend through the main body 1660 and into thethrough-bore of the knob 1658 such that the stopper 0016 is disposed inthe main body 1660 and at least a portion of the threads 1678 of theshaft 1662 and the slit end 1672 disposed outside the main body 1660 andinside the knob body 1658 a. The shaft threads 1678 operably engage theinternal threads 1658 d of the knob 1658 in forming a threadedconnection with the knob 1658 to form a cannulation or reception forreceiving a bone pin, such as bone pin 600, of uniform diameter, or bonepin 700 of varying diameter. A portion of the shaft 1662 or the stopper0016 can include an at least partially spherical surface to permit thebone pin 600 or 700 to orient relative to the main body 1660, and canhave at least one anti-rotation feature such as protrusion 1676 adaptedto sit in a key way in the main body 1660.

In operation, the tightening of the knob 1658 pushes the slit end 1672of the shaft 1662, guided by the tapered internal surface or structureof the knob body 1658 a, toward or through the opposing end 1658 c ofthe knob 1658. The slit end 1672 is compressed circumferentially ontothe bone pin 600 or 700 at the opposing end 1658 c of the knob 1658 asthe slit end 1672 is pushed through the smaller opening at the opposingend 1658 c of the knob 1658, and thus, clamping onto the bone pin 600 or700 by interference fit.

The main body 1660 is configured to extend through the pivot structures1616, 1626, and 1636 of the first and second external fixationcomponents 1602 and 1604 and the connector 1606. The main body 1660 hasa cylindrical body with proximal protrusions 1682 for engaging with keyways 1620 on the inner surface of the pivot structure 1616 of the firstexternal fixation component 1602 and distal protrusions 1684 forengaging with key ways 1630 on the inner surface of the pivot structure1626 of the second external fixation component 1604. The main body 1660has inner surface configured to operably interact with the shaft 1662 toprovide both angular rotation of the shaft 1662 relative to the mainbody 1660 and anti-rotation of the shaft 1662 during locking. The innersurface of the main body includes one or more key way 1686 for capturingthe protrusions 1676 of the shaft 1662 for rotational stability, concavesurfaces 1688 for interacting with the at least partially sphericalstopper 0016 of the shaft 1662 and tapered or conical surface 1690 forproviding angular rotation of the shaft 1662, and slotted geometry 1692that accepts a ring clip 1664 for preventing the variable position shaft1662 to exit the main body 1660 once the cartridge system 1610 iscompletely assembled.

The ankle-spanning external fixation system 1600 is assembled byfirstly, snap-fitting together the first external fixation component1602, the second external fixation component 1604 and the connector 1606via male/female ends on their pivot structures 1616, 1626 and 1636. Whenthe first external fixation component 1602, the second external fixationcomponent 1604 and the connector 1606 are rotated into their closedstate, the key ways 1620, 1630 and 1642 of the respective pivotstructures 1616, 1626 and 1636 become aligned and allow the assembledcartridge system 1610 to slide in. Once the cartridge system 1610 is inplace, the first external fixation component 1602, the second externalfixation component 1604 and the connector 1606 can be opened up to thedesired position according to anatomical considerations. Once thecurrent embodiment 1600 is deployed and in position, the cartridgesystem can be adjusted and then locked in place by further tighteningknob 1658, which in turn locks the first external fixation component1602, the second external fixation component 1604 and the connector 1606via the interactions of rough surfaces 1618, 1638, 1640 and 1628.

Referring now to FIGS. 62-64, an alternative embodiment 1700 of theankle-spanning external fixation system 1600 is illustrated wherein thesystem 1700 includes the curved foot frame 1706 comprising a U-shapedposterior (e.g., first) frame section and a U-shaped inferior (e.g.,second) section connected at the base by a straight frame section. Thetwo U-shaped frame sections are arranged to lie on different planesforming an angle of about 90 degrees. Other angles also lie within thespirit and scope of the various embodiments of the present invention.

Referring now to FIGS. 65-69, an alternative embodiment 1800 of theankle-spanning external fixation system 1700 is illustrated wherein thefirst external fixation component 1802, second external fixationcomponent 1804, and the foot frame 1810 are each of modularconstruction, comprising two or more straight and/or curved segmentsjoined together via plug-socket joints and fixed in place by threading,snap-fitting or interference-fitting. Each of the first externalfixation component 1802, second external fixation component 1804, andthe foot frame 1810 of the system 1800 can also be made into a unitarystructure or unitary modular structure by molding or forming permanentconnection among the subcomponents or segments by welding, soldering,crimping, brazing, and gluing/epoxying. The system 1800 can besingle-use or disposable.

Referring now to FIG. 70, a flow diagram of an embodiment of a method3000 for fixating a bone fixator system about a target joint is shown.The method may be performed by a variety of users, including healthcareprofessionals, technicians, and patients installing and/or adjusting thebone fixator system. The bone fixator system used to implement themethod may be or include features of any of the fixation systemsdisclosed herein (e.g., external fixation systems 100, 200, 800, 900,1000, 1100, 1200, 1400, 1500, 1600, 1700, 1800, etc.) and the clampingdevices used herein to implement the method may be or include featuresof any of the clamping devices and systems disclosed herein (e.g., clampsystems 300, 400, 500, 1300, 2600, etc.).

At 3010, components of a bone fixator system are aligned with targetbone(s) about a target joint to be fixated. The target joint may be anelbow, a knee, an ankle, etc. For example, the bone fixator system mayinclude a first fixation component and a second fixation component, thefirst fixation component may be aligned relative to a first target bonedisposed adjacent to the target joint, and the second fixation componentmay be aligned relative to a second target bone disposed adjacent to thetarget joint on another side of the knee from the first target bone.

A clamp is also aligned relative to a target bone. For example, a clampmay be aligned with the target bone based on a desired position and/ororientation of a bone pin to be attached to the bone and secured orotherwise received by the clamp. The clamp may also be received on oneof the fixation components of the bone fixator system while aligning theclamp.

At 3012, a bone pin is attached (e.g., secured, coupled, drilled in,etc.) to a target bone using a clamp as a drill guide. For example, theclamp may define a through-bore configured to receive the bone pin. Thethrough-bore may be used to sight or otherwise identify a targetposition on a surface of the target bone at which the bone pin is to beattached to the target bone. The bone pin is received through thethrough-bore of the clamp, and may be drilled into the bone. The clampmay be locked about the bone pin.

At 3014, the clamp is locked to the bone fixation component. Forexample, the clamp may include a pair of jaws defining an aperturethrough which the bone fixation component may pass, and a locking devicemay be used to force the jaws to compress the bone fixation component inorder to lock the clamp to the bone fixation component.

At 3016, it is determined whether the bone fixation system is disposedin a desired orientation (e.g., position and/or angle relative to targetjoint, target bones, etc.). If the bone fixation system is not disposedin a desired orientation (e.g., the orientation is not acceptable), thenat 3018, clamp(s) may be unlocked, providing degrees of freedom allowingfor adjustment of the bone fixation system and components of the bonefixation system.

In some embodiments, determining whether the bone fixation system isdisposed in a desired orientation includes comparing an observed jointstatus of the target joint to a desired joint status of the targetjoint. For example, a clinical goal for the joint may include aparticular joint status (e.g., a degree of flexure of the joint,relative angles of the bones about the joint, etc.) to be achieved usingthe bone fixation system.

If it is determined that the bone fixation is disposed in a desiredorientation, then at 3020, it is determined whether an additional bonepin needs to be attached. If it is determined that an additional bonepin is needed, then the procedure outlined in steps 3010, 3012, 3014,3016, and 3018 may be followed to provide an additional clamp and attachan additional bone pin.

If it is determined that an additional bone pin is not needed, then at3022, angle(s) between various components in the bone fixation system,such as between a first fixation component and a second fixationcomponent, may be adjusted.

At 3024, after adjusting angles of the bone fixation system, it isdetermined whether the bone fixation system is disposed in a desiredorientation. If it is determined that the bone fixation system is notdisposed in a desired orientation, then at 3026, any locked clamp(s) andbone fixation component(s) are unlocked, allowing for adjustment of theorientation of the bone fixation system, such as by adjusting angle(s)between bone fixation components. An angle of a clamp relative to a bonefixation component may be adjusted, such as by adjusting an angledefined by a longitudinal axis of the bone fixation component and aplane transverse to a through-bore of the clamp in which the bonefixation component is received. A position of the clamp relative to thebone fixation component may be adjusted as well, such as by shiftingand/or sliding the bone fixation component and the clamp relative to oneanother.

In some embodiments, the bone fixation system is configured to befixated about a target ankle joint. The bone fixation system includes afirst frame which may be aligned about a first target bone of the lowerextremity adjacent to the target ankle joint. The bone fixation systemalso includes a second frame which may be aligned to at least partiallysurround the target ankle. For example, the second frame may include aninferior frame portion and a posterior frame portion. Fixating such abone fixation system may include aligning the first frame with a firsttarget bone of the lower extremity, aligning the second frame such thatthe inferior frame is disposed in an inferior position relative to thetarget ankle joint and such that the posterior frame is disposed in aposterior position relative to the target ankle joint, aligning a firstclamp with the first target bone, attaching a first bone pin to thefirst target bone using the first clamp as a drill guide, and lockingthe first clamp to the first frame. In some embodiments, such a bonefixation system may be further fixated by aligning a second clamp with asecond target bone (e.g., a bone of the foot or of the heel), attachinga second bone pin to the second target bone using the second clamp as adrill guide, and locking the second clamp to the second frame.

If it is determined that the bone fixation system is disposed in adesired orientation, then at 3028, all clamp(s) and bone fixationcomponent(s) are locked. For example, locking devices may be used tolock clamp(s) to respective bone fixation component(s). In someembodiments, bone fixation components may be engaged and locked usingfasteners or other engagement devices as disclosed herein.

B. Clamping Devices and Systems with Locking Assembly

Referring now to FIGS. 71-76B, various embodiments of a clamping device3100 including a locking assembly are shown. The clamping device 3100can be similar to the clamp systems 300, 400, 500, and/or 2600 describedherein, with the exception of the features described further below,including the lever mechanism and jaw structures.

In some embodiments, a clamping device (or system) includes a clamp bodyand a locking assembly. The clamp body includes a first jaw and a secondjaw, and defines a first channel configured to accommodate a fixationelement (e.g., an external fixation rail, external fixation componentsdescribed herein such as external fixation component 102, etc.) along alongitudinal axis of the first channel. The first jaw defines a firstopening and the second jaw defines a second opening. The lockingassembly includes a first locking element, a second locking element, anda lever configured to couple to the second locking element. The firstlocking element includes a first end and a shaft portion extending fromthe first end. The shaft portion is sized to pass through the firstopening and the second opening. The second opening is sized to restrictthe first end from passing through the second opening. The first lockingelement defines a second channel sized to receive a bone pin. Thelocking assembly is configured to reduce a distance between the firstjaw and the second jaw responsive to rotation of the second lockingelement relative to the first locking element. The lever is configuredto be attached to the second locking element and rotated about thesecond locking element from a first position to a second position tocause the distance between the first jaw and the second jaw to bereduced further while the first end is in contact with the secondopening.

Referring now to FIG. 71, a clamping device 3100 includes a clamp body3102 and a locking assembly 3108. The clamp body 3102 includes a firstjaw 3104 and a second jaw 3106. The locking assembly 3108 includes alever 3110 (e.g., an extension, a rotatable actuator). The lockingassembly is configured to receive a bone pin 600. The clamp body 3102can define a first channel configured to accommodate a fixation elementalong a longitudinal axis of the first channel. The first channel can bedefined between surfaces of the first jaw 3104 and the second jaw 3106(e.g., surfaces that face each other). The longitudinal axis can passthrough the first channel, and can be equidistant from some, most, orall points of the surfaces of the first jaw 3104 and second jaw 3106that define the first channel.

Referring now to FIGS. 72A-72B, the bone pin 600 can be received throughthe lever 3110 into a remainder of the locking assembly 3100 and theclamp body 3102. Features of the locking assembly 3100 configured toreceive, couple to, secure, clamp, and/or manipulate the bone pin 600are described further herein. As shown in FIGS. 72A-72B, the lever 3110defines a lever channel 3111. The lever channel 3111 can receive thebone pin 600. The lever channel 3111 can be sized to accommodate thebone pin 600 (e.g., the lever channel 3111 has a diameter or a maximumdimension defined across the lever channel 3111 that is greater than adiameter or maximum dimension defined across the bone pin 600. The leverchannel 3111 can have a lever channel radius that is greater than orequal to a radius of an inner surface of a shaft portion of a firstlocking element of the locking assembly 3100 (see, e.g., first lockingelement 3120 of FIG. 73A). The lever channel 3111 can help a user guidethe bone pin 600 through the locking assembly 3100 to a point on apatient to which the bone pin 600 is to be attached. For example, thebone pin 600 may be placed or rested against the lever 3110 to stabilizethe bone pin 600 and align the bone pin 600 with the lever channel 3111(and the channel 3134 of the locking assembly 3100). The lever channel3111 can be coaxial with the channel 3134 to receive the bone pin 600from the channel 3134. While FIGS. 72A-72B illustrate the bone pin 600as being inserted first through a first end of the clamping deviceproximal to the first jaw 3104, in some embodiments, the bone pin 600may also be inserted through a second end of the clamping deviceproximal to the second jaw 3106.

Referring now to FIGS. 73A-73D, various components of embodiments of theclamping device 3100 are illustrated. The locking assembly 3108 caninclude a first locking element 3120, a second locking element 3140, anda third locking element 3160. The components of the locking assembly3108 can be configured to couple to one another, to receive the bone pin600, and/or to apply forces to the clamp body 3102 causing the first jaw3104 and second jaw 3106 to move closer to one another.

The first locking element 3120 can be similar to the shafts 306, 406,2606 described herein. The first locking element 3120 is configured tosurround a portion of the bone pin 600, and may include a flexiblematerial allowing the first locking element 3120 to be compressedagainst the bone pin 600. The first locking element 3120 includes afirst end 3122 and a shaft portion 3128 extending from the first end3122. In some embodiments, the first end 3122 includes protrusions 3124extending outward from the first end 3122. The protrusions 3124 can bereceived by a portion of the second jaw 3106, helping to align the firstlocking element 3120 with the second jaw 3106 and/or restrict motion ofthe first locking element 3120 relative to the second jaw 3106.

As shown in FIG. 73A, the first end 3122 has a spheroid shape (e.g., ashape defined such that most or all points on an exterior surface of thespheroid correspond to an ellipse rotated about one of its principleaxes). In various embodiments, the first end 3122 can have variousshapes (e.g., rectangular solid, cylindrical, shapes defined by a stepfunction, conical or triangular solid). As described further herein withreference to FIG. 75A, the first end 3120 can define a maximum diameterthat is greater than a minimum diameter of a second opening of thesecond jaw 3106, which can restrict motion of the first end 3122relative to the second opening. The maximum diameter can be less than ashaft diameter of the shaft 3128.

The shaft portion 3128 is sized to pass through the first jaw 3104 andthe second jaw 3106 (e.g., via openings of the first jaw 3104 and thesecond jaw 3106). The shaft portion 3128 can include an engagementfeature configured to couple the first locking element 3120 to anothercomponent (e.g., the second locking element 3140). For example, FIG. 73Ashows the engagement features as threads 3130; the engagement featurecould additional be or include recesses, protrusions, interdigitation,or other features configured to engage another component such that thefirst locking element 3120 may move together with the other componentwhile engaged. The threads 3130 can extend along an outer surface of thefirst locking element 3120 adjacent to a second end 3126 of the firstlocking element 3120 opposite the first end 3122.

In some embodiments, the first locking element 3120 defines a channel3134 sized to accommodate the bone pin 600. For example, a maximumdimension across the channel 3134 can be greater than a maximumdimension across the bone pin 600. The first locking element 3120 and/orthe channel 3134 can define a longitudinal axis 3136 (e.g., a channelaxis) passing through the channel 3134. The longitudinal axis 3136 canbe equidistant from some or all of the points of the channel 3134 (e.g.,from an inner surface or wall of the first locking element 3120 definingthe channel).

In some embodiments, the first locking element 3120 includes extensions3132 (e.g., slits, protrusions). The extensions 3132 extend inward fromthe first end 3122 and the shaft portion 3128 (e.g., from an innersurface or wall of the first locking element 3120 defining the channel3134). The extensions 3132 can be configured to apply a force againstthe bone pin 600 in response to compression of the first locking element3120 (e.g., as the first locking element 3120 is tightened or compressedby the second locking element 3140 or the second jaw 3106).

Referring further to FIG. 73B, the second locking element 3140 caninclude a second locking element body 3142. The second locking elementbody 3142 can be sized to receive the shaft portion 3128 of the firstlocking element 3120. The second locking element body 3142 is shown tohave a cylindrical shape to facilitate rotation of the second lockingelement body 3142 in a compact space; however, in various embodiments,the second locking element body 3142 can have other shapes (e.g.,polygonal, rectangular).

The second locking element 3140 includes at least one rotational couplerelement 3144 extending from the second locking element body 3142. Therotational coupler elements 3144 are configured to couple to (e.g.,engage) the lever 3110, such that the lever 3110 can be rotated aboutthe second locking element body 3142. For example, the second lockingelement 3140 and/or the rotational coupler elements 3144 can define arotational axis 3150 passing through the second locking element 3140about which the lever 3110 can rotate.

The second locking element 3140 includes an inner surface 3146 defininga channel in which the shaft portion 3128 of the first locking element3120 can be received. For example, a maximum dimension across thechannel (e.g., from a first point on the inner surface 3146 to a secondpoint opposite the first point) can be greater than or equal to amaximum dimension of an outer surface of the shaft portion 3128. Theinner surface 3146 includes an engagement feature configured to coupleto or engage with the first locking element 3120. The engagement featuremay be complementary to an engagement feature of the first lockingelement 3120. For example, as shown in FIG. 73B, the inner surface 3146includes thread receiving members 3148 configured to engage the threads3130 of the first locking element 3120. The second locking element 3140and/or the inner surface 3146 can define a longitudinal axis 3152. Thelongitudinal axis 3152 may be equidistant from some, most, or all pointson the inner surface 3146. The longitudinal axis 3152 may be in the sameplane as and/or perpendicular to the rotation axis 3150. In someembodiments, the lever 3110, when coupled to the rotational couplerelements 3144, can apply a force to the rotational coupler elements 3144in a direction perpendicular to the longitudinal axis 3152, causing thesecond locking element 3120 to rotate about the longitudinal axis 3152.In some embodiments, the locking assembly 3108 defines an engagementaxis along which the bone pin 600 is received. The second lockingelement 3140 may be rotated about the engagement axis. For example, theengagement axis may coincide with the longitudinal axes 3136, 3152 whenthe second locking element 3140 is engaged to the first locking element3120.

As the thread receiving members 3148 engage the threads 3130 of thefirst locking element 3120, the second locking element 3140 can becoupled, engaged, attached, and/or secured to the first locking element3120. The longitudinal axis 3152 may align with the longitudinal axis3136 when the first locking element 3120 is received in the channel ofthe second locking element 3140 (e.g., when the thread receiving members3148 engage the threads 3130).

The engagement of the receiving members 3148 and the threads 3130 mayrestrict motion between the first locking element 3120 and the secondlocking element 3140. For example, when the thread receiving members3148 engage the threads 3130, a force applied to the first lockingelement 3120 along the longitudinal axis 3136, or to the second lockingelement 3140 along the longitudinal axis 3152, may be insufficient(e.g., less than a threshold force that is significantly greater thancan be applied to the locking elements 3120, 3140 by a typical user) tocause the first locking element 3120 to move along the longitudinal axis3152 relative to the first locking element 3120. Instead, rotation ofthe second locking element 3140 about the shaft portion 3128 of thefirst locking element 3120, due to the engagement of the threads 3130and the thread receiving members 3148, allows the first locking element3120 to be translated through the second locking element 3140. In someembodiments, a portion of the shaft portion 3128 having the threads 3130includes a material that is flexible or compressible, such that engagingthe second locking element 3140 to the first locking element 3120 aboutthe threads 3130 (or another engagement feature) flexes, bends, orcompresses the shaft portion 3128 against the bone pin 600 (e.g., theextension 3132 may be forced against the bone pin 600), which canincrease locking of the bone pin 600.

Referring now to FIG. 73C, the third locking element 3160 can include abase portion 3162. The base portion 3162 is attachable to the first jaw3104 (e.g., to a surface of the first jaw 3104 opposite the second jaw3106). The third locking element 3160 can include a receiving portion3164 extending from the base portion 3162. The receiving portion 3164defines a cavity 3166. The cavity 3166 is configured or sized to receivethe second locking element 3140. For example, a maximum dimension acrossthe cavity 3166 can be greater than a maximum dimension across thesecond locking element 3140.

The receiving portion 3164 can include or define a receiving wall 3168.As described further with reference to FIGS. 74A-74B, the receiving wall3168 can be shaped or sized to receive or match a cam wall of the lever3110 (e.g., a curvature of the receiving wall 3168 is complementary to acorresponding curvature of the cam wall). As the lever 3110 is rotatedabout the second locking element 3140, the lever 3110 applies a varyingforce against the receiving wall 3168, which can cause the third lockingelement 3160 to move relative to the second locking element 3140 and/orapply a force against the first jaw 3104. In some embodiments, featuresof the third locking element 3160 may be excluded, or may beincorporated in the lever 3110 or the second locking element 3140. Forexample, the lever 3110 may be configured to attach to the first jaw3104, such that rotation of the lever 3110 against the first jaw 3104causes a varying force to be applied to the first jaw 3104.

As shown in FIG. 73D, the lever 3110 includes a cam wall 3112. An innersurface 3202 of the cam wall 3112 (e.g., a surface facing towards thelever channel 3111) and/or an inner cam wall 3204 defines a center 3206.The inner surface 3202 and the inner cam wall 3204 are shaped,configured, and/or sized to engage the rotational coupler elements 3144of the second locking element body 3142. For example, a radius ofcurvature of the inner cam wall 3204 and/or the inner surface 3202 canmatch (e.g., is equal to or is greater than an amount less than athreshold amount, resulting in a fit between the lever 3110 and therotational coupler element 3144) a radius of curvature of the rotationalcoupler elements 3144. As the lever 3110 rotates about second lockingelement 3140, the rotation axis 3140 of the second locking element 3140aligns with the center(s) 3206 of the lever 3110.

In some embodiments, the lever 3110 includes a tab wall 3210. The tabwall 3120 is configured to be received by a corresponding tab receiver3212 of the third locking element 3160. For example, when the lever 3110is rotated about the rotation axis 3150 of the second locking element3140 to the second position, the tab receiver 3212 can be coupled to orsecure the tab wall 3210, restricting rotation of the lever 3110 towardsthe first position. In addition, the tab wall 3210 can provide a userwith a lever arm to facilitate rotation of the lever 3110 both about thelongitudinal axis 3152 of the second locking element 3140 when thesecond locking element 3140 is being threaded onto the first lockingelement 3120 to translate the first locking element 3120 through thesecond locking element 3140 (e.g., translate the first locking element3120 in a direction from the clamp body 3102 towards the second lockingelement 3140), and about the rotation axis 3150 as the lever 3110 isrotated from the first position towards the second position. In someembodiments, a length of the lever 3110 (e.g., from the center 3206 to apoint at which the tab wall 3210 terminates) is greater than a thresholdlength required to apply sufficient force to rotate the lever 3110 fromthe first position to the second position to clamp the fixation elementand the bone pin 600, and less than a length (e.g., a greatest length)of the third locking element 3160 and/or a length (e.g., a greatestlength) of the clamp body 3102, providing a compact, effective mechanismfor clamping the fixation element and the bone pin 600 (e.g., securingpositions and/or orientations of the fixation element and the bone pin600 relative to one another in space).

Referring now to FIGS. 74A-74B, various features of the engagement andinteraction between the lever 3110, the third locking element 3160, andthe clamp body 3102 are illustrated. The cam wall 3112 defines a firstradius r₁, and a second radius r₂. The second radius r₂ is greater thanthe first radius r₁. The radii r₁, r₂ can be defined from a center ofrotation of the cam wall 3112. The center of rotation of the cam wall3112 may correspond to a center of an inner surface of the cam wall 3112(see FIG. 73D) (e.g., a center that is equidistant from some, most, orall points on an inner cam wall configured to couple to the rotationalcoupler element 3144, such that when the lever 3110 rotates about thesecond locking element 3140, the rotation axis 3150 of the secondlocking element 3140 coincides with the center of the inner surfaceand/or the center of rotation).

In some embodiments, the lever 3110 is configured to rotate from a firstposition or orientation (e.g., a position or orientation as shown inFIG. 74A, in which the lever channel 3111 is aligned with a longitudinalaxis of the bone pin 600) to a second position. The second position maybe a position or orientation as shown in FIG. 74B, in which the cam wall3112 may be flush with the receiving wall 3168 and/or the lever 3110 canbe secured by a retaining feature of the third locking element 3160. Thesecond position or orientation may be any other position or orientationas the lever 3110 is rotated between the position shown in FIG. 74A andthe position shown in FIG. 74B. The rotation from the first position tothe second position may occur about the center of rotation of the camwall 3112, such as when the lever 3110 is coupled to the second lockingelement 3140, such that the lever 3110 rotates about the rotation axis3150 of the second locking element 3140. As the lever 3110 rotates fromthe first position to the second position, the radius of the cam wall3112 in contact with a contact point 3170 of the receiving wall 3168increases from the first radius r₁ to the second radius r₂.

In embodiments, configurations, and/or arrangements of the clampingdevice 3100 in which the third locking element 3160 is attached to thefirst jaw 3104, the first end 3122 of the first locking element 3120 isin contact with the second jaw 3106 on a side of the second jaw 3106opposite the first jaw 3104, the second locking element 3140 is engagedto the first locking element 3120, and the lever 3110 is coupled to thesecond locking element 3140, the distance between the center of rotationof the lever 3110 and the first end 3122 is fixed such that the increasein radius of the cam wall 3112 contacting the receiving wall 3168increases a distance between the second locking element 3140 and thebase portion 3162, causing the first end 3122 to pull the second jaw3106 towards the first jaw 3104 to offset the increased distance betweenthe second locking element 3140 and the base portion 3162. In someembodiments, the increased distance between the second locking element3140 and the base portion 3162 is equal to a radius difference Arbetween the first radius ri and the second radius r₂; the offsetdistance by which the second jaw 3106 moves towards the first jaw 3104may be equal to the radius difference Ar.

In some embodiments, the clamping device 3100 can include a lock releasemember 3169. The lock release member 3169 is configured to releasablyengage, lock, secure, attach, or otherwise couple the lever 3110 to thethird locking element 3160. For example, the lock release member 3169can be configured to apply a force to a first side of the lever 3110opposite where the lever 3110 is received by the third locking element3160 to hold or secure the lever 3110 in position. In some embodiments,the lock release member 3169 is or includes actuation member, such as abutton, configured to engage or disengage the lever 3110 responsive toactuation (e.g., responsive to being pushed or pulled). In someembodiments, the lock release member 3169 is or includes a keyconfigured to be slidably received and removed from a slot of the thirdlocking element 3160. In some embodiments, the lock release member 3169can facilitate selective locking of the clamping device 3100, such as toallow a medical professional performing a procedure using the clampingdevice 3100 to lock or unlock the lever 3110 to make adjustments to theclamping device 3100; the lock release member 3169 may be configuredsuch that only the medical professional may actuate the lock releasemember 3169, such as when the lock release member 3169 is a key.

Referring now to FIGS. 75A-75B, various features of interactions betweenthe components of the clamping device 3100 are illustrated. The firstjaw 3104 defines a first opening 3107 (e.g., an interior wall or innerwall defines the first opening 3107). The first opening 3107 is sized toreceive the shaft portion 3128 of the first locking element 3120. Forexample, the shaft portion 3128 can define a shaft dimension 3129 (e.g.,a radius as illustrated, or a corresponding diameter) in a directionperpendicular to the longitudinal axis of the shaft portion 3128 (e.g.,longitudinal axis 3136 shown in FIG. 73A). The first opening 3107 candefine a first diameter 3188 (e.g., a first wall diameter) that isgreater than or equal to the shaft diameter 3129, and a second diameter3190 (e.g., a second wall diameter) that is greater than the firstdiameter 3188. In some embodiments, such as shown in FIGS. 75A-75B, aprofile of the first opening 3107 is smooth (e.g., macroscopicallysmooth, while in other embodiments, the first opening 3107 may have aprofile defined by a step function or non-smooth or non-continuousprofile). For example, the first opening 3107 may be defined by aconical inner surface of the first jaw 3104.

Gaps or spaces between the wall defining the first opening 3107 and theshaft portion 3128 may define a range of motion, such as for tilting thefirst locking element 3120 (and thus the bone pin 600 when the firstlocking element 3120 has received the bone pin 600). The range of motionmay be based on an angle α defined between a first portion of the wallhaving the first diameter 3188, and a second portion of the wall havingthe second diameter 3190 or another diameter greater than the firstdiameter 3188. In some embodiments, the angle α is approximately 165degrees (e.g., 150 degrees; greater than 90 degrees and less than orequal to 180 degrees; greater than or equal to 120 degrees and less thanor equal to 175 degrees; greater than or equal to 135 degrees and lessthan or equal to 170 degrees; greater than or equal to 140 degrees andless than or equal to 160 degrees). In some embodiments, such as shownin FIG. 75A, the second portion of the wall having the second diameter3190 may be angled relative to the first portion of the wall having thefirst diameter 3188 to define a tilt angle β. The tilt angle R mayrepresent a range of motion by which the first locking element 3120 maybe tilted relative to an orientation in which a longitudinal axis 601 ofthe bone pin 600, or the corresponding longitudinal axes of the firstlocking element 3120 and/or the second locking element 3140, areperpendicular to a plane 3192 that is parallel to surfaces of the firstjaw 3104 and the second jaw 3106, and/or a plane that is parallel toouter rims of the first opening 3107 or the second opening 3109. Forexample, if the angle α is 165, then the tilt angle β may be 15 degrees,such that the first locking element 3120 may tilt by 15 degrees (e.g.,the first locking element 3120 may tilt by a 30 degree range of conicalmotion) when the outer surface of the shaft portion 3128 of the firstlocking element 3120 is in contact with the wall defining the firstopening 3107. As further described with reference to FIGS. 76A-76B,allowing the first locking element 3120 to tilt or otherwise be orientedthroughout a range of motion (e.g., a conical range of motion) withinthe first opening 3107 may advantageously allow a user to dynamicallyarrange the clamping device 3100, and thus an external fixation systemutilizing the clamping device 3100, in arrangements or configurationsduring assembly of the external fixation system that are not possiblewith existing solutions (which may require fixing an angle between afixation element and a bone pin throughout the assembly process). Insome embodiments, the first opening 3107 is conical.

The second jaw 3106 defines a second opening 3109. In some embodiments,while the shaft portion 3128 of the first locking element 3120 is sizedor configured to pass through the second opening 3109, the secondopening 3109 is sized or configured to restrict or prevent the first end3122 of the first locking element 3120 to pass through the secondopening 3109 (e.g., be moved from a first side of the second opening3109 opposite the first jaw 3104 to a second side of the second opening3109 adjacent to the first jaw 3104). In such embodiments, if a force isapplied to the first locking element 3120 in a direction that would movethe first end 3122 towards the first jaw 3104 while the first end 3122is in contact with the second opening 3109 (e.g., with a wall of thesecond jaw 3106 defining the second opening 3109), the force will betransmitted from the first end 3122 to the second jaw 3106. The firstlocking element 3120 may thus cause the second jaw 3106 to move towardsthe first jaw 3104.

In some embodiments, the clamp body 3102 includes a first material thatis flexible (e.g., bends or otherwise changes in shape in response to amechanical force). In response to a force applied to the second jaw 3106by the first end 3122, the clamp body 3102 may be reduced in size (e.g.,the second jaw 3106 may move towards the first jaw 3104; a distancebetween the second jaw 3106 and the first 3104 may decrease). As thesecond jaw 3106 moves towards the first jaw 3104, a clamping forceapplied to a fixation element received in the first channel between thejaws 3104, 3106 may be increased, increasing security of the fixationelement. In some embodiments, the first end 3122 includes a secondmaterial that is flexible. The first material of the clamp body 3102 maybe more flexible than the second material of the first end 3122, suchthat any bending, flexing, or other change in shape that occurs inresponse to a force applied by the first end 3122 to the second jaw 3106will predominantly (or totally) result in movement of the second jaw3106 towards the first jaw 3104. The first material of the clamp body3102 may be located between the first jaw 3104 and the second jaw 3106,acting as a pivoting member for movement of the second jaw 3106 towardsthe first jaw 3104.

In some embodiments, the first end 3122 may include a second materialthat is flexible or compressible. The second material may be moreflexible or compressible than a wall defining the second opening 3109.As a force is applied by the first end 3122 against the second opening3109, some or all of the force may cause the first end 3122 to compressor flex away from the second opening 3109 (e.g., compress or flexinwards), thus transmitting the force to the bone pin 600 and increasinga clamping force for securing the bone pin 600. In some embodiments,where the first locking element 3120 includes slits 3132, the forceapplied by the first end 3122 against the second opening 3109 mayadditionally or alternatively cause the slits 3132 to move towards thebone pin 600, similarly increasing a clamping force for securing thebone pin 600. The second material may be configured to be compressed ina plane orthogonal to the channel 3134 in response to a force applied bythe second opening 3109 against the first end 3122.

The second opening 3109 (e.g., a wall defining the second opening 3109)can include a first portion defining a first diameter 3180 (e.g., adimension across the second opening 3109) that is greater than a maximumdiameter 3184 (e.g., a dimension across the first end 3122, a dimensionperpendicular to longitudinal axis 3136 of the first locking element3120) of the first end 3122, and a second portion defining a seconddiameter 3182 that is less than a minimum diameter 3186 (e.g., adimension across the first end 3122, a dimension perpendicular to alongitudinal axis 3136 of the first locking element 3120) of the firstend 3122. As such, the first end 3122 may not pass any further throughthe second opening 3109 towards the first jaw 3104 once the minimumdiameter 3186 of the first end 3122 contacts the second diameter 3182.The second diameter 3182 can be closer to the first jaw 3104 than thefirst diameter 3180, such that the second portion is configured torestrict the first end 3122 from being moved further towards the firstjaw when the first end is in contact with the second portion.

As further described with regards to FIGS. 76A-76B, the first end 3122may be tilted within the second opening 3109, allowing the bone pin 600to be tilted (e.g., to be tilted throughout a conical path or conicalrange of motion). In some embodiments, the range of tilting may bedetermined based on at least one of the first diameter 3180 of thesecond opening 3109, the second diameter 3182 of the second opening3109, the first diameter 3188 of the first opening 3107, and/or thesecond diameter 3190 of the first opening 3109. In other words, thespace defined by the first opening 3107 and/or the space defined by thesecond opening 3109, enable the first locking element 3120 to bere-oriented within the first opening 3107 and the second opening 3109.

Referring further to FIGS. 75A-75B, and back to FIGS. 74A-74B, as thelever 3110 rotates from the first position to the second position, theportion of the cam wall 3112 contacting the receiving wall 3168 of thethird locking element 3160 increases in radius from r₁ to r₂, increasingthe distance between the center of rotation of the lever 3110 and thebase portion 3162. As the second locking element 3140 is fixed to thelever 3110 (e.g., when the lever 3110 is rotatably coupled to the secondlocking element 3140), increasing the distance between the center ofrotation of the lever 3110 and the base portion 3162 increases adistance 3114 between the second locking element 3140 and the thirdlocking element 3160 (and/or between the second locking element 3140 andthe clamp body 3102), such as to move the second locking element 3140away from the clamp body 3102. While the second locking element 3140 isengaged to the first locking element 3120 (e.g., while thread receivingmembers 3148 engage threads 3130 of the first locking element 3120), thedistance between the second locking element 3140 and the first end 3122may be fixed, resulting in a force causing the first end 3122 to movetowards the first jaw 3104, where force is transmitted to the second jaw3106. The distance 3114 may be equal to the radius difference Ar as thelever 3110 rotates from the first position to the second position.

Referring further to FIGS. 75A-75B, in some embodiments, the clamp body3102 includes at least one engagement member 3117 extending from anouter surface of the first jaw 3104 (e.g., a surface of the first jaw3104). For example, the clamp body 3102 can include an annularprotrusion 3116 similar to the annular protrusion 312 or the annularprotrusion 512 described herein that terminates in engagement members3117. The base portion 3162 of the third locking element 3160 mayinclude at least one engagement receiving feature 3161 configured toengage the engagement members 3117. In some embodiments, the engagementreceiving feature 3161 is configured to ratchet, such that the thirdlocking element 3120 may be rotated in a first direction (e.g.,clockwise), but not in second direction (e.g., counter-clockwise). Insome embodiments, the engagement members 3117 include at least one ofinterdigitation or radial serrations. In some embodiments, the thirdlocking element 3160 is configured to selectively engage first jaw 3104(e.g., only when the lever 3110 is in the second position), allowing thebone pin 600 to be tilted unless then third locking element 3160 isengaged to the first jaw.

Referring now to FIGS. 76A-76B, the range of motion defined by the firstopening 3107 and/or the second opening 3109 (see FIGS. 75A-75B) allowthe first locking element 3120, and thus the bone pin 600, to be rotated(e.g., conically rotated, tilted, conically tilted), enabling a user toarrange the clamping device 3100 in a variety of orientations whileassembling the clamping device 3100. When the lever 3110 is brought tothe second position, the additional security and/or locking provided mayalso secure the clamping device 3100 in an orientation where the bonepin 600 is tilted. For example, the clamping device 3100 may beassembled while the lever 3110 is in the first position, at which pointthe first locking element 3120 may still be tilted; when the lever 3110is brought to the second position, then additional security and/orlocking may apply a sufficient force to restrict further tilting of thefirst locking element 3120.

Clamping devices and systems manufactured in accordance with theembodiments disclosed herein can improve external fixation by providinga compact, elegant mechanism to clamp, lock, or otherwise secure a bonepin and an external fixation element (e.g., a rail) relative to oneanother. For example, such systems can allow a surgeon or other user toarrange the components of the clamping system in a desired orientation,rotate the second locking element about the first locking element totighten the components of the system, perform any additional adjustmentsor movements that may be necessary, and then complete the locking of thesystem by rotating the lever from the first position to the secondposition, which can take advantage of the lever arm provided by thelever to increase the force that can be applied to compress and tightenagainst the bone pin and rail, while maintaining a form factor that iscompact and/or has a low profile, reducing the opportunity for contactwith surrounding components or the environment to disturb the clampingof the bone pin and rail.

The principles, preferred embodiments and modes of operation of thepresent invention have been made apparent in the foregoing description.

Although the embodiments are numbered with, for example, “first,”“second,” or “third,” or “fourth,” the ordinal numbers do not implypriorities of the embodiments.

Since many modifications, variations and changes in detail can be madeto the described embodiments of the invention, it is intended that allmatters in the foregoing description and shown in the accompanyingdrawings be interpreted as illustrative and not in a limiting sense.Thus, the scope of the invention should be determined by the appendedclaims and their legal equivalents.

What is claimed is:
 1. A locking assembly, comprising: a first lockingcomponent including a base, the base including a first surface and a camreceiver extending from the first surface to a cam receiver edge, thecam receiver configured to receive a cam, the cam receiver edge having afirst edge point closest to the first surface, the first surfacedefining an opening which is not parallel to a plane passing through thecam receiver; a second locking component including a first end, a secondend, and a shaft portion extending from the first end to the second end,the second locking component configured to be coupled to the firstlocking component to translate through the opening along a first axis;the cam including a cam edge and defining a center of rotation, a firstradius extending from the center of rotation to a first point of the camedge, and a second radius extending from the center of rotation to asecond point of the cam edge, the cam defines a channel configured toreceive a bone pin, wherein the first radius is less than the secondradius; the cam configured to be rotated along the cam receiver edgeabout a second axis which is not parallel to the first axis from a firstposition at which the center of rotation is spaced from the first edgepoint by the first radius to a second position at which the center ofrotation is spaced from the first edge point by the second radius. 2.The locking assembly of claim 1, wherein the second locking componentincludes one or more threads configured to engage corresponding threadreceiving members of the first locking component to be rotated whilebeing translated along the first axis.
 3. The locking assembly of claim1, wherein the cam receiver edge is concave.
 4. The locking assembly ofclaim 1, wherein the cam includes a tab extending from the cam edge andthe first locking component includes a tab receiver extending from thebase, the tab receiver configured to removably secure the tab to thebase when the cam is at the second position.
 5. The locking assembly ofclaim 4, further comprising a lock release member configured to causethe tab receiver to release the tab.
 6. The locking assembly of claim 1,wherein the channel is configured to contact the bone pin when the camis at the first position.
 7. The locking assembly of claim 1, whereinrotating the cam from the first position to the second position adjustsa distance between the first end of the second locking component and thecenter of rotation of the cam.
 8. The locking assembly of claim 1,wherein the first axis is perpendicular to the second axis.
 9. Thelocking assembly of claim 1, wherein the cam includes a second cam edgespaced from and parallel to the cam edge.
 10. A surgical kit for anexternal fixator system, comprising: a first locking component includinga base, the base including a first surface and a cam receiver extendingfrom the first surface to a cam receiver edge, the cam receiverconfigured to receive a cam, the cam receiver edge having a first edgepoint closest to the first surface, the first surface defining anopening which is not parallel to a plane passing through the camreceiver; a second locking component including a first end, a secondend, and a shaft portion extending from the first end to the second end,the shaft portion including at least one rotational engagement featureconfigured to be coupled to the first locking component to translate thesecond locking component through the opening along a first axis whilebeing rotated about the first axis; the cam including a cam edge anddefining a center of rotation, a first radius extending from the centerof rotation to a first point of the cam edge, and a second radiusextending from the center of rotation to a second point of the cam edge,the cam defines a channel configured to receive a bone pin, wherein thefirst radius is less than the second radius; the cam configured to berotated along the cam receiver edge about a second axis which is notparallel to the first axis from a first position at which the center ofrotation is spaced from the first edge point by the first radius to asecond position at which the center of rotation is spaced from the firstedge point by the second radius.
 11. The surgical kit of claim 10,wherein the first locking component includes one or more threadreceiving members configured to engage the at least one rotationalengagement feature of the second locking component.
 12. The surgical kitof claim 10, wherein the cam receiver edge is concave.
 13. The surgicalkit of claim 10, wherein the cam includes a tab extending from the camedge and the first locking component includes a tab receiver extendingfrom the base, the tab receiver configured to removably secure the tabto the base when the cam is at the second position.
 14. The surgical kitof claim 13, further comprising a lock release member configured tocause the tab receiver to release the tab.
 15. The surgical kit of claim10, wherein the channel is configured to contact the bone pin when thecam is at the first position.
 16. The surgical kit of claim 10, whereinrotating the cam from the first position to the second position adjustsa distance between the first end of the second locking component and thecenter of rotation of the cam.
 17. The surgical kit of claim 10, whereinthe first axis is perpendicular to the second axis.
 18. The surgical kitof claim 10, wherein the cam includes a second cam edge spaced from andparallel to the cam edge.
 19. A locking assembly, comprising: a firstlocking component including a base, the base including a first surfaceand a cam receiver extending from the first surface to a cam receiveredge, the cam receiver configured to receive a cam, the cam receiveredge having a first edge point closest to the first surface, the firstsurface defining an opening which is not parallel to a plane passingthrough the cam receiver; a second locking component including a firstend, a second end, and a shaft portion extending from the first end tothe second end, the second locking component configured to be coupled tothe first locking component to translate through the opening along afirst axis; the cam including a cam edge and defining a center ofrotation, a first radius extending from the center of rotation to afirst point of the cam edge, and a second radius extending from thecenter of rotation to a second point of the cam edge, the cam defines achannel configured to receive a bone pin; the cam configured to berotated along the cam receiver edge about a second axis which is notparallel to the first axis from a first position at which the center ofrotation is spaced from the first edge point by the first radius to asecond position at which the center of rotation is spaced from the firstedge point by the second radius, wherein the cam includes a tabextending from the cam edge and the first locking component includes atab receiver extending from the base, the tab receiver configured toremovably secure the tab to the base when the cam is at the secondposition.
 20. The locking assembly of claim 19, wherein the cam receiveredge is concave.